<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03748667</url>
  </required_header>
  <id_info>
    <org_study_id>CEIC 18/53</org_study_id>
    <nct_id>NCT03748667</nct_id>
  </id_info>
  <brief_title>Accuracy for Predicting Deep Submucosal Invasion</brief_title>
  <acronym>NBIBLI</acronym>
  <official_title>Diagnostic Accuracy of Deep Submucosal Invasion: White Light Endoscopy vs Invasive Pattern Based on NBI/BLI ± Chromoendoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Althaia Xarxa Assistencial Universitària de Manresa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario La Fe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clínico Universitario Lozano Blesa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Center, Japan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Germans Trias i Pujol Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario 12 de Octubre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario Ramon y Cajal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>San Francisco Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario Virgen de la Arrixaca</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Comarcal de Alcañiz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro Medico Teknon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Althaia Xarxa Assistencial Universitària de Manresa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of this study is to determine whether the assessment of the invasive pattern&#xD;
      based on NBI with dual focus/magnification or BLI with magnification ± chromoendoscopy&#xD;
      (NBI+CE) for predicting deep invasion is significantly more accurate than the assessment&#xD;
      based on white light endoscopy (WLE), carried out by trained endoscopists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A video with the lesion assessment, without any data on the patient, will be recorded in a&#xD;
      device connected to the processor provided by the Principal Investigator. The name of the&#xD;
      file will be the record ID. All the lesions will be tested by the same endoscopist in vivo&#xD;
      and an assistant will fulfill the data collection sheet during the colonoscopy.&#xD;
&#xD;
      First, the lesions will be cleaned and observed in a stable position. Size, location,&#xD;
      morphology, demarcated areas, and gross morphological malignant features will be evaluated.&#xD;
      Based on these WLE characteristics, a deep invasion prediction will be performed (control&#xD;
      test). Second, the lesion will be assessed using NBI with near focus or magnification or BLI&#xD;
      with magnification. A second cleaning with pronase (or N-acetylcysteine if pronase is not&#xD;
      available) if the surface cannot be clearly observed because of the presence of mucus or if&#xD;
      crystal violet is going to be used. Crystal violet 0.05% will be used in case of polyps type&#xD;
      2B in the JNET classification or lesions with a demarcated area. A non-traumatic catheter (or&#xD;
      spray catheter) will be used to spray the crystal violet over the lesion. A final prediction&#xD;
      of deep invasion will be performed for NBI or BLI ± CE (test evaluated).&#xD;
&#xD;
      The use of a cap to observe the bottom of the lesion, fix the lesion close to the endoscope&#xD;
      or to observe the lesion underwater immersion is strongly recommended.&#xD;
&#xD;
      The resection technique will be decided upon according to the local experience. In case of&#xD;
      endoscopy resection (cold snare, EMR, ESD, full thickness), lesions will be removed via the&#xD;
      anus (not through the endoscopy channel) in order to preserve their integrity. Although EMR&#xD;
      is performed, if possible, lesions will be referred to the pathologist well oriented and&#xD;
      pinned out on a cork based, as is standard procedure in ESD.&#xD;
&#xD;
      In order to ensure that endoscopic assessment is performed before the histology evaluation,&#xD;
      both diagnostic assessments (control test and test evaluated) will be recorded on the REDCap&#xD;
      database on the day of the colonoscopy. REDCap records the time and date of all changes in&#xD;
      the variables' results. The remaining variables (demographic data, etc.) will be recorded on&#xD;
      the data collection sheet and copied later into REDCap.&#xD;
&#xD;
      Videos of the lesion assessments will be sent to the Principal Investigator. Centralized&#xD;
      visualization will be conducted to detect protocol violations and to exclude lesions from the&#xD;
      study.&#xD;
&#xD;
      A blinded histology assessment will be conducted by the local pathologist and if a carcinoma&#xD;
      with submucosal invasion is diagnosed, histology slides will be referred for an additional&#xD;
      blinded and centralized histology evaluation at the end of the study.&#xD;
&#xD;
      Pathologists participating in the histological phase will assess all the slides with&#xD;
      submucosal invasion and will collect the histological factors associated with lymph node&#xD;
      metastasis.&#xD;
&#xD;
      Finally, investigators participating in the translational phase will refer paraffin blocks of&#xD;
      10 lesions of each JNET category (2A, 2B and 3) for genetic tests (sequencing of a panel of&#xD;
      45 genes and analysis of alterations in the number of copies of the genome).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The presence or absence of deep invasion according to the control test (WLE)</measure>
    <time_frame>One day</time_frame>
    <description>Deep invasion will subjectively be diagnosed based on the presence of gross morphological malignant features, morphology and size. No single malignant feature, specific morphology or size is required. The importance given to each criterion and the final diagnosis of deep invasion is based on the personal experience of the endoscopist.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The presence or absence of deep invasion according to the test evaluated (NBI/BLI +/- CE)</measure>
    <time_frame>One day</time_frame>
    <description>Deep invasion will be diagnosed in case of:&#xD;
JNET type 3 or&#xD;
JNET 2B + Kudo Vn pit pattern or&#xD;
JNET 2B and Kudo Vi pit pattern fulfilling all the following criteria: severe Kudo Vi pit pattern + presence of a demarcated area + size (demarcated area) &gt;6 mm for PG or 3 mm for NPG.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The presence or absence of deep invasion according to the gold standard (histology)</measure>
    <time_frame>One day</time_frame>
    <description>Deep invasion will be diagnosed if sm invasion ≥1000 μm is measured according to the Japanese guidelines by the central pathologists.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of any genetic mutations</measure>
    <time_frame>one day</time_frame>
    <description>Sequencing of a panel of colorectal cancer genes: the 45 genes will be sequenced frequently mutated in colorectal cancer, through the protocols established in the center Executor: APC, TP53, FBXW7, SOX9, ATM, SMAD4, KRAS, PIK3CA, AMER1, FAT4, ARID1A, BRAF, NRAS, CTNNB1, TCF7L2, ERBB2, MET, EGFR, HRAS, SETD2, DLC1, CDKN2A, PTEN, ARID2, FAT1, POLE, POLD1, NOTCH1, BRCA2, LRP1B, KMT2C, KMT2D, DAPK1, CSMD1, MUC16, ADAMTS15, SYNE1, PCLO, ZFHX4, RYR3, RYR2, RELN, IRS2, GNAS, DMBT1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of genome copies using SNP-arrays</measure>
    <time_frame>one day</time_frame>
    <description>Number of copies using SNP-arrays.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1158</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Colorectal Polyp</condition>
  <arm_group>
    <arm_group_label>Patients with colorectal polyps</arm_group_label>
    <description>Patients with non-pedunculated type 0 lesions in Paris classification (not obvious cancers) larger than 10 mm</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>White light endoscopy (WLE)</intervention_name>
    <description>Subjective endoscopic assessment of deep submucosal invasion based on the presence of gross morphological malignant features, morphology and size.</description>
    <arm_group_label>Patients with colorectal polyps</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)</intervention_name>
    <description>Endoscopic assessment of deep submucosal invasion with NBI and dual focus/magnification or BLI and magnification. In the case of demarcated areas or JNET 2B, Kudo pit pattern assessment with crystal violet will be performed.</description>
    <arm_group_label>Patients with colorectal polyps</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Paraffin blocks of colorectal polyps&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients &gt; 18 years old who undergo a colonoscopy for any reason&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Non-pedunculated type 0 lesions in Paris classification (not obvious cancers)&#xD;
&#xD;
          -  Lesions larger than 10 mm&#xD;
&#xD;
        Exclusion criteria are:&#xD;
&#xD;
          -  Lesions assessed as JNET 1 by the endoscopist or serrated by the pathologist&#xD;
&#xD;
          -  Previous biopsy or resection attempt&#xD;
&#xD;
          -  Previous CT, MR or USE&#xD;
&#xD;
          -  Unavailable histology&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  Informed consent not obtained&#xD;
&#xD;
          -  Protocol violation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ignasi Puig, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Althaia Xarxa Assistencial Universitària de Manresa</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ignasi Puig, MD, PhD</last_name>
    <phone>0034938742112</phone>
    <phone_ext>3840</phone_ext>
    <email>ignasipuig@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anna Cano, Data manager</last_name>
    <phone>0034938742112</phone>
    <phone_ext>3840</phone_ext>
    <email>gergroup@althaia.cat</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>San Francisco Veterans Affairs Medical Center. University of California</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <email>endoresection@me.com</email>
    </contact>
    <investigator>
      <last_name>Tonya Kaltenbach</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <email>mcgills@email.unc.edu</email>
    </contact>
    <investigator>
      <last_name>Sarah McGill</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>tasakamo529@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Taku Sakamoto</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <state>Aragón</state>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <email>angel.ferrandez@telefonica.net</email>
    </contact>
    <investigator>
      <last_name>Ángel Ferrández</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol (Can Ruti)</name>
      <address>
        <city>Badalona</city>
        <state>Cataluña</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>hugoikuo@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Hugo Uchima</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>MPELLISE@clinic.cat</email>
    </contact>
    <investigator>
      <last_name>Maria Pellisé</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Miriam Cuatrecasas</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Liseth Rivero</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <email>JCAMPS@clinic.cat</email>
    </contact>
    <investigator>
      <last_name>Jordi Camps</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Althaia. Xarxa Assistencial Universitària de Manresa</name>
      <address>
        <city>Manresa</city>
        <state>Cataluña</state>
        <zip>08243</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <email>orosinol@althaia.cat</email>
    </contact>
    <investigator>
      <last_name>Òria Rosiñol</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politécnico de La Fe</name>
      <address>
        <city>Valencia</city>
        <state>Comunidad Valenciana</state>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <email>mbustamantebalen@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Marco Bustamante</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Virgen de la Arrixaca</name>
      <address>
        <city>El Palmar</city>
        <state>Murcia</state>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <email>ono.akiko@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Akiko Ono</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Comarcal de Alcañiz</name>
      <address>
        <city>Alcañiz</city>
        <state>Teruel</state>
        <zip>44600</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>dramarinas@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Marina Solano</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centro Médico Teknon</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>hugoikuo@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Hugo Uchima</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>enrodesan@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Enrique Rodríguez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>josecarlos.marin@salud.madrid.org</email>
    </contact>
    <investigator>
      <last_name>José Carlos Marín</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Backes Y, Moss A, Reitsma JB, Siersema PD, Moons LM. Narrow Band Imaging, Magnifying Chromoendoscopy, and Gross Morphological Features for the Optical Diagnosis of T1 Colorectal Cancer and Deep Submucosal Invasion: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2017 Jan;112(1):54-64. doi: 10.1038/ajg.2016.403. Epub 2016 Sep 20.</citation>
    <PMID>27644737</PMID>
  </reference>
  <reference>
    <citation>Hayashi N, Tanaka S, Hewett DG, Kaltenbach TR, Sano Y, Ponchon T, Saunders BP, Rex DK, Soetikno RM. Endoscopic prediction of deep submucosal invasive carcinoma: validation of the narrow-band imaging international colorectal endoscopic (NICE) classification. Gastrointest Endosc. 2013 Oct;78(4):625-32. doi: 10.1016/j.gie.2013.04.185. Epub 2013 Jul 30.</citation>
    <PMID>23910062</PMID>
  </reference>
  <reference>
    <citation>Sano Y, Tanaka S, Kudo SE, Saito S, Matsuda T, Wada Y, Fujii T, Ikematsu H, Uraoka T, Kobayashi N, Nakamura H, Hotta K, Horimatsu T, Sakamoto N, Fu KI, Tsuruta O, Kawano H, Kashida H, Takeuchi Y, Machida H, Kusaka T, Yoshida N, Hirata I, Terai T, Yamano HO, Kaneko K, Nakajima T, Sakamoto T, Yamaguchi Y, Tamai N, Nakano N, Hayashi N, Oka S, Iwatate M, Ishikawa H, Murakami Y, Yoshida S, Saito Y. Narrow-band imaging (NBI) magnifying endoscopic classification of colorectal tumors proposed by the Japan NBI Expert Team. Dig Endosc. 2016 Jul;28(5):526-33. doi: 10.1111/den.12644. Epub 2016 Apr 20.</citation>
    <PMID>26927367</PMID>
  </reference>
  <reference>
    <citation>Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.</citation>
    <PMID>30296432</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Althaia Xarxa Assistencial Universitària de Manresa</investigator_affiliation>
    <investigator_full_name>Ignasi Puig del Castillo</investigator_full_name>
    <investigator_title>Gastroenterology consultant, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Endoscopy</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Invasive pattern</keyword>
  <keyword>Polypectomy</keyword>
  <keyword>NBI</keyword>
  <keyword>BLI</keyword>
  <keyword>Deep submucosal invasion</keyword>
  <keyword>JNET</keyword>
  <keyword>Kudo pit pattern</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03748667
org study id: CEIC 18/53
nct id: NCT03748667
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main aim of this study is to determine whether the assessment of the invasive pattern
      based on NBI with dual focus/magnification or BLI with magnification ± chromoendoscopy
      (NBI+CE) for predicting deep invasion is significantly more accurate than the assessment
      based on white light endoscopy (WLE), carried out by trained endoscopists.
A video with the lesion assessment, without any data on the patient, will be recorded in a
      device connected to the processor provided by the Principal Investigator. The name of the
      file will be the record ID. All the lesions will be tested by the same endoscopist in vivo
      and an assistant will fulfill the data collection sheet during the colonoscopy.

      First, the lesions will be cleaned and observed in a stable position. Size, location,
      morphology, demarcated areas, and gross morphological malignant features will be evaluated.
      Based on these WLE characteristics, a deep invasion prediction will be performed (control
      test). Second, the lesion will be assessed using NBI with near focus or magnification or BLI
      with magnification. A second cleaning with pronase (or N-acetylcysteine if pronase is not
      available) if the surface cannot be clearly observed because of the presence of mucus or if
      crystal violet is going to be used. Crystal violet 0.05% will be used in case of polyps type
      2B in the JNET classification or lesions with a demarcated area. A non-traumatic catheter (or
      spray catheter) will be used to spray the crystal violet over the lesion. A final prediction
      of deep invasion will be performed for NBI or BLI ± CE (test evaluated).

      The use of a cap to observe the bottom of the lesion, fix the lesion close to the endoscope
      or to observe the lesion underwater immersion is strongly recommended.

      The resection technique will be decided upon according to the local experience. In case of
      endoscopy resection (cold snare, EMR, ESD, full thickness), lesions will be removed via the
      anus (not through the endoscopy channel) in order to preserve their integrity. Although EMR
      is performed, if possible, lesions will be referred to the pathologist well oriented and
      pinned out on a cork based, as is standard procedure in ESD.

      In order to ensure that endoscopic assessment is performed before the histology evaluation,
      both diagnostic assessments (control test and test evaluated) will be recorded on the REDCap
      database on the day of the colonoscopy. REDCap records the time and date of all changes in
      the variables' results. The remaining variables (demographic data, etc.) will be recorded on
      the data collection sheet and copied later into REDCap.

      Videos of the lesion assessments will be sent to the Principal Investigator. Centralized
      visualization will be conducted to detect protocol violations and to exclude lesions from the
      study.

      A blinded histology assessment will be conducted by the local pathologist and if a carcinoma
      with submucosal invasion is diagnosed, histology slides will be referred for an additional
      blinded and centralized histology evaluation at the end of the study.

      Pathologists participating in the histological phase will assess all the slides with
      submucosal invasion and will collect the histological factors associated with lymph node
      metastasis.

      Finally, investigators participating in the translational phase will refer paraffin blocks of
      10 lesions of each JNET category (2A, 2B and 3) for genetic tests (sequencing of a panel of
      45 genes and analysis of alterations in the number of copies of the genome).
observational model: Cohort
time perspective: Cross-Sectional
measure: The presence or absence of deep invasion according to the control test (WLE)
time frame: One day
description: Deep invasion will subjectively be diagnosed based on the presence of gross morphological malignant features, morphology and size. No single malignant feature, specific morphology or size is required. The importance given to each criterion and the final diagnosis of deep invasion is based on the personal experience of the endoscopist.
measure: The presence or absence of deep invasion according to the test evaluated (NBI/BLI +/- CE)
time frame: One day
description: Deep invasion will be diagnosed in case of:
JNET type 3 or
JNET 2B + Kudo Vn pit pattern or
JNET 2B and Kudo Vi pit pattern fulfilling all the following criteria: severe Kudo Vi pit pattern + presence of a demarcated area + size (demarcated area) >6 mm for PG or 3 mm for NPG.
measure: The presence or absence of deep invasion according to the gold standard (histology)
time frame: One day
description: Deep invasion will be diagnosed if sm invasion ≥1000 μm is measured according to the Japanese guidelines by the central pathologists.
measure: Presence of any genetic mutations
time frame: one day
description: Sequencing of a panel of colorectal cancer genes: the 45 genes will be sequenced frequently mutated in colorectal cancer, through the protocols established in the center Executor: APC, TP53, FBXW7, SOX9, ATM, SMAD4, KRAS, PIK3CA, AMER1, FAT4, ARID1A, BRAF, NRAS, CTNNB1, TCF7L2, ERBB2, MET, EGFR, HRAS, SETD2, DLC1, CDKN2A, PTEN, ARID2, FAT1, POLE, POLD1, NOTCH1, BRCA2, LRP1B, KMT2C, KMT2D, DAPK1, CSMD1, MUC16, ADAMTS15, SYNE1, PCLO, ZFHX4, RYR3, RYR2, RELN, IRS2, GNAS, DMBT1.
measure: Number of genome copies using SNP-arrays
time frame: one day
description: Number of copies using SNP-arrays.
arm group label: Patients with colorectal polyps
description: Patients with non-pedunculated type 0 lesions in Paris classification (not obvious cancers) larger than 10 mm
intervention type: Diagnostic Test
intervention name: White light endoscopy (WLE)
description: Subjective endoscopic assessment of deep submucosal invasion based on the presence of gross morphological malignant features, morphology and size.
arm group label: Patients with colorectal polyps
intervention type: Diagnostic Test
intervention name: NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)
description: Endoscopic assessment of deep submucosal invasion with NBI and dual focus/magnification or BLI and magnification. In the case of demarcated areas or JNET 2B, Kudo pit pattern assessment with crystal violet will be performed.
arm group label: Patients with colorectal polyps
Paraffin blocks of colorectal polyps
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ignasi Puig, MD, PhD
role: Principal Investigator
affiliation: Althaia Xarxa Assistencial Universitària de Manresa
last name: Ignasi Puig, MD, PhD
phone: 0034938742112
phone ext: 3840
email: ignasipuig@gmail.com
last name: Anna Cano, Data manager
phone: 0034938742112
phone ext: 3840
email: gergroup@althaia.cat
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country: Japan
country: Spain
country: United States
citation: Backes Y, Moss A, Reitsma JB, Siersema PD, Moons LM. Narrow Band Imaging, Magnifying Chromoendoscopy, and Gross Morphological Features for the Optical Diagnosis of T1 Colorectal Cancer and Deep Submucosal Invasion: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2017 Jan;112(1):54-64. doi: 10.1038/ajg.2016.403. Epub 2016 Sep 20.
PMID: 27644737
citation: Hayashi N, Tanaka S, Hewett DG, Kaltenbach TR, Sano Y, Ponchon T, Saunders BP, Rex DK, Soetikno RM. Endoscopic prediction of deep submucosal invasive carcinoma: validation of the narrow-band imaging international colorectal endoscopic (NICE) classification. Gastrointest Endosc. 2013 Oct;78(4):625-32. doi: 10.1016/j.gie.2013.04.185. Epub 2013 Jul 30.
PMID: 23910062
citation: Sano Y, Tanaka S, Kudo SE, Saito S, Matsuda T, Wada Y, Fujii T, Ikematsu H, Uraoka T, Kobayashi N, Nakamura H, Hotta K, Horimatsu T, Sakamoto N, Fu KI, Tsuruta O, Kawano H, Kashida H, Takeuchi Y, Machida H, Kusaka T, Yoshida N, Hirata I, Terai T, Yamano HO, Kaneko K, Nakajima T, Sakamoto T, Yamaguchi Y, Tamai N, Nakano N, Hayashi N, Oka S, Iwatate M, Ishikawa H, Murakami Y, Yoshida S, Saito Y. Narrow-band imaging (NBI) magnifying endoscopic classification of colorectal tumors proposed by the Japan NBI Expert Team. Dig Endosc. 2016 Jul;28(5):526-33. doi: 10.1111/den.12644. Epub 2016 Apr 20.
PMID: 26927367
citation: Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.
PMID: 30296432
responsible party type: Principal Investigator
investigator affiliation: Althaia Xarxa Assistencial Universitària de Manresa
investigator full name: Ignasi Puig del Castillo
investigator title: Gastroenterology consultant, MD, PhD
mesh term: Colorectal Neoplasms
sharing ipd: No