xml: <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/NCT06040632</url>
    </required_header>
    <id_info>
      <org_study_id>IMPROVE-pT1</org_study_id>
      <nct_id>NCT06040632</nct_id>
    </id_info>
    <brief_title>Accurate Allocation of Completion Resection in Early Colorectal Cancer</brief_title>
    <acronym>IMPROVE-pT1</acronym>
    <official_title>Accurate Allocation of Completion Resection in Early Colorectal Cancer: an Observational Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Aarhus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Copenhagen University Hospital at Herlev</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Regional Hospital Horsens</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Aarhus University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Regional Hospital Randers</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Aarhus</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>
        After introducing a nationwide screening program for colorectal cancer (CRC) in Denmark, more&#xD;
        cases of early-stage CRC are being detected. Cancers in the earliest stages are often removed&#xD;
        locally, either during the diagnostic colonoscopy or through planned minimally invasive&#xD;
        surgery.&#xD;
  &#xD;
        This early detection of cancer, and thereby an improved prognosis, is a positive feature but&#xD;
        has also introduced a new clinical dilemma. Is the patient fully cured by the local&#xD;
        resection, or do they need further surgery? Whether further surgery is recommended at the&#xD;
        Multi-Disciplinary Team (MDT) board meeting depends on the outcome of specific criteria from&#xD;
        the histopathological assessment of the locally removed specimen.&#xD;
  &#xD;
        The presence of these criteria does not, however, translate directly into the presence of&#xD;
        residual disease - merely into a theoretically increased risk. In Denmark, after surgery, the&#xD;
        fraction of cases with residual disease has been around 15% for many years. In the remaining&#xD;
        85% of cases, local removal alone was curative - and the surgery appears excessive.&#xD;
  &#xD;
        Investigating blood samples for the presence of circulating tumor DNA (ctDNA) is a new and&#xD;
        promising method for cancer detection. The method utilizes that cancer cells release ctDNA&#xD;
        into the circulation. ctDNA detected in blood drawn from a patient a few days after local&#xD;
        removal of a tumor indicates that residual disease is present and further treatment, such as&#xD;
        surgery, is needed.&#xD;
  &#xD;
        The purpose of this study is to investigate, whether analyses of ctDNA can correctly identify&#xD;
        patients with residual disease after local removal of early CRC. If this identification&#xD;
        proves accurate, many patients can be spared further surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        KEY POINTS&#xD;
  &#xD;
          -  85% of patients receiving completion bowel resection after local removal of pT1 CRC are&#xD;
             overtreated.&#xD;
  &#xD;
          -  ctDNA is a biomarker of residual cancer disease and could help identify those patients,&#xD;
             where completion bowel resection is necessary, sparing those that are already cured.&#xD;
  &#xD;
        GOALS ● To explore ctDNA analysis for identification of the patient subgroup with residual&#xD;
        disease after local excision of pT1 tumors and hence need for completion resection.&#xD;
  &#xD;
        PERSPECTIVES&#xD;
  &#xD;
        ● Practice-changing evidence for ctDNA-guided risk-stratification for pT1 CRCs after local&#xD;
        excision, an important and well-recognized clinical dilemma in the management of CRC.&#xD;
  &#xD;
        PROJECT DESCRIPTION After the introduction of the nationwide screening program for CRC in&#xD;
        Denmark, the number of very early-stage CRC cases (pT1) has increased. Many of these early&#xD;
        cancers present macroscopically as polyps and are removed by local excision. Despite the&#xD;
        early detection leading to improved prognosis, locally resected pT1 CRC presents a clinical&#xD;
        dilemma, due to the small, but significant, risk of regional lymph node metastasis. This&#xD;
        introduces the question: Was the patient cured by local resection alone? - or is segmental&#xD;
        bowel resection (termed completion resection) required to remove metastatic regional lymph&#xD;
        nodes and cure the patient? The present guideline for managing this clinical situation has&#xD;
        led to massive overtreatment. Resection is recommended if the local excision was non-radical&#xD;
        or if the histopathological assessment revealed ≥1 histopathological risk factor. However,&#xD;
        only 15% of the patients receiving completion resection are diagnosed with metastatic lymph&#xD;
        nodes. For the remaining 85%, the local excision was curative, and the completion resection&#xD;
        was an overtreatment. Each year in Denmark, 130 colon and 40 rectal completion resections are&#xD;
        performed. The complication rate after bowel resection is substantial. Following colonic&#xD;
        resections 11% of patients suffer from surgical complications, 7% from medical complications,&#xD;
        and 4% from a combination of both. For rectal cancer resection, the corresponding fractions&#xD;
        are 20%, 5%, and 5%, respectively. The associated overall 30-day mortality is 1.3%, rising to&#xD;
        1.5% after surgical complications and to 11% after medical or combined complications.&#xD;
        Furthermore, many patients suffer from long-term or even chronic postoperative morbidities&#xD;
        and late organ effects such as pain, bowel obstruction, and hernia formation.&#xD;
  &#xD;
        This highlights the significant importance of accurately choosing patients who indeed require&#xD;
        completion resection for a definite cure.&#xD;
  &#xD;
        In the current study the use of ctDNA will be explored for identification of the patient&#xD;
        subgroup with residual disease after local excision of pT1 tumors and, hence, the need for&#xD;
        completion resection.&#xD;
  &#xD;
        The hypotheses are (1) ctDNA can be used to identify patients with residual disease requiring&#xD;
        completion resection and (2) patients without detectable ctDNA were cured by the local&#xD;
        resection, and therefore can be spared completion resection.&#xD;
  &#xD;
        Investigators will conduct a prospective, observational feasibility study, assessing the&#xD;
        association between pre-completion-resection ctDNA status and the presence of residual&#xD;
        disease established by pathological evaluation of the resected specimen. A total of 67&#xD;
        patients, who have undergone local resection of pT1 CRC and who are planned to receive a&#xD;
        completion resection will be included. Blood samples will be collected before the completion&#xD;
        resection. Tumor tissue will be obtained from the locally resected pT1 tumor.&#xD;
  &#xD;
        ctDNA analysis will be performed using the recently published whole genome sequencing-based&#xD;
        MRDetect approach.&#xD;
  &#xD;
        Feasibility measures: 1) recruitment of &gt;30 patients every 6 months, 2) a ctDNA positivity&#xD;
        rate ≥70%, and 3) accuracy of ctDNA status predicting lymph node status. Using the pathology&#xD;
        evaluation of the completion resection specimen as gold standard.&#xD;
  &#xD;
        If the performance criteria are met, the study will be transitioned into an open-label 1:1&#xD;
        randomized trial comparing the effect of ctDNA-guided patient selection for completion&#xD;
        resection to current practice, which is completion resection to all. If the performance&#xD;
        criteria are not met, the method will be re-evaluated to optimize sensitivity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>ctDNA analysis</measure>
      <time_frame>After recruitment of the last patient, we expect that ctDNA analyses can be performed within 6 months</time_frame>
      <description>Blood samples will be categorized as either ctDNA positive or negative</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pathological evaluation of the resected specimen from the completion resection</measure>
      <time_frame>After recruitment of the last patient, these data will be available (expected in spring 2024)</time_frame>
      <description>Evaluations will be used to group patients into residual and no residual disease after local resection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>30- and 90-day mortality related to the completion resection</measure>
      <time_frame>After recruitment of the last patient, these data will be extracted from the patient's medical records within 12 months</time_frame>
      <description>Mortality data for secondary outcomes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative morbidities</measure>
      <time_frame>After recruitment of the last patient, these data will be extracted from the patient's medical records within 6 months</time_frame>
      <description>Morbidity data for secondary outcomes</description>
    </secondary_outcome>
    <enrollment type="Anticipated">67</enrollment>
    <condition>Colorectal Cancer</condition>
    <condition>Colorectal Polyp</condition>
    <condition>Colorectal Cancer Stage I</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood samples will be drawn prior to and around 14 days after completion resection.&#xD;
  &#xD;
        Blood draw: 80 mL - 7 x EDTA tubes, 1 x serum tube&#xD;
  &#xD;
        Formalin-fixed paraffin-embedded (FFPE) tissue from the local treatment will be obtained from&#xD;
        the relevant Pathological departments, for the purpose of extracting DNA for mutational&#xD;
        analysis.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients having undergone local resection of pT1 colorectal cancer and with planned&#xD;
          completion resection, as recommended by the local MDT board&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients having undergone local resection of pT1 colorectal cancer and with planned&#xD;
               completion resection, as recommended by the local MDT board&#xD;
  &#xD;
                 -  The reason for the planning of completion resection may be non-micro radical&#xD;
                    tumor removal, piece-meal resection making assessment of resection margin&#xD;
                    impossible or the presence of one or more histological risk factors&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients not able to understand information about the study and/or give informed&#xD;
               consent&#xD;
  &#xD;
            -  Patients not accepting blood samples stored in biobank&#xD;
  &#xD;
            -  Cases with non-obtainable primary tumor tissue, required for the conduction of&#xD;
               mutational analyses&#xD;
  &#xD;
            -  Other recent (within 5 years) or current malignant disease, except basocellular&#xD;
               carcinoma of the skin&#xD;
  &#xD;
            -  Planned completion resection due to other factors, such as patient's wish or&#xD;
               hereditary disposition for CRC, and with the absence of risk factors mentioned above&#xD;
  &#xD;
            -  Withdrawal of consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mads F Klein, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Copenhagen University Hospital at Herlev</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jeppe Kildsig, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Copenhagen University Hospital at Herlev</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Kåre A Gotschalck, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Regional Hospital Horsens</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Anne-Sofie Kannerup, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Regional Hospital Randers</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lene H Iversen, MD, DMSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aarhus University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Claus L Andersen, PhD</last_name>
      <phone>+45 7845 5319</phone>
      <email>cla@clin.au.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mads F Klein, MD, PhD</last_name>
      <email>mads.falk.klein@regionh.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Bispebjerg Hospital</name>
        <address>
          <city>Copenhagen</city>
          <state>Capital Region Of Denmark</state>
          <zip>2400</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nis Hallundbæk Schlesinger</last_name>
        <email>Nis.Hallundbaek.Schlesinger@regionh.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Herlev Hospital</name>
        <address>
          <city>Herlev</city>
          <state>Capital Region Of Denmark</state>
          <zip>2730</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mads F Klein, MD, Ph.D</last_name>
        <email>mads.falk.klein@regionh.dk</email>
      </contact>
      <contact_backup>
        <last_name>Jeppe Kildsig, MD</last_name>
        <email>Jeppe.Kildsig@regionh.dk</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Aarhus University Hospital</name>
        <address>
          <city>Aarhus</city>
          <state>Central Denmark Region</state>
          <zip>8000</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lene H Iversen, MD, DMSc</last_name>
        <email>lene.h.iversen@dadlnet.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Gødstrup Hospital</name>
        <address>
          <city>Herning</city>
          <state>Central Denmark Region</state>
          <zip>7400</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Claudia Jaensch, MD, PhD</last_name>
        <email>Claudia.Jaensch@goedstrup.rm.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Regional Hospital Horsens</name>
        <address>
          <city>Horsens</city>
          <state>Central Denmark Region</state>
          <zip>8700</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kåre A Gotschalck, MD, Ph.D</last_name>
        <email>kaarsune@rm.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Regional Hospital Randers</name>
        <address>
          <city>Randers</city>
          <state>Central Denmark Region</state>
          <zip>8930</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Peter Bondeven, MD, PhD</last_name>
        <email>petefred@rm.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Regional Hospital Viborg</name>
        <address>
          <city>Viborg</city>
          <state>Central Denmark Region</state>
          <zip>8800</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Uffe S Løve, MD, PhD</last_name>
        <email>uffescho@rm.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Aalborg University Hospital</name>
        <address>
          <city>Aalborg</city>
          <state>North Denmark Region</state>
          <zip>9000</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ole Thorlacius-Ussing, MD, PhD</last_name>
        <email>otu@rn.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Odense University Hospital</name>
        <address>
          <city>Odense</city>
          <state>The Region Of Southern Denmark</state>
          <zip>5000</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Per Vadgaard Andersen, MD, PhD</last_name>
        <email>Per.vadgaard.andersen@rsyd.dk</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <link>
      <url>https://www.sundhed.dk/content/cms/81/4681_dccg-klinisk-temarapport-2018.pdf</url>
      <description>Danish Colorectal Cancer Group - 2018 Report on postoperative surgical complications (in Danish)</description>
    </link>
    <reference>
      <citation>Zviran A, Schulman RC, Shah M, Hill STK, Deochand S, Khamnei CC, Maloney D, Patel K, Liao W, Widman AJ, Wong P, Callahan MK, Ha G, Reed S, Rotem D, Frederick D, Sharova T, Miao B, Kim T, Gydush G, Rhoades J, Huang KY, Omans ND, Bolan PO, Lipsky AH, Ang C, Malbari M, Spinelli CF, Kazancioglu S, Runnels AM, Fennessey S, Stolte C, Gaiti F, Inghirami GG, Adalsteinsson V, Houck-Loomis B, Ishii J, Wolchok JD, Boland G, Robine N, Altorki NK, Landau DA. Genome-wide cell-free DNA mutational integration enables ultra-sensitive cancer monitoring. Nat Med. 2020 Jul;26(7):1114-1124. doi: 10.1038/s41591-020-0915-3. Epub 2020 Jun 1.</citation>
      <PMID>32483360</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040632
  org study id: IMPROVE-pT1
  nct id: NCT06040632
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  After introducing a nationwide screening program for colorectal cancer (CRC) in Denmark, more
        cases of early-stage CRC are being detected. Cancers in the earliest stages are often removed
        locally, either during the diagnostic colonoscopy or through planned minimally invasive
        surgery.
  
        This early detection of cancer, and thereby an improved prognosis, is a positive feature but
        has also introduced a new clinical dilemma. Is the patient fully cured by the local
        resection, or do they need further surgery? Whether further surgery is recommended at the
        Multi-Disciplinary Team (MDT) board meeting depends on the outcome of specific criteria from
        the histopathological assessment of the locally removed specimen.
  
        The presence of these criteria does not, however, translate directly into the presence of
        residual disease - merely into a theoretically increased risk. In Denmark, after surgery, the
        fraction of cases with residual disease has been around 15% for many years. In the remaining
        85% of cases, local removal alone was curative - and the surgery appears excessive.
  
        Investigating blood samples for the presence of circulating tumor DNA (ctDNA) is a new and
        promising method for cancer detection. The method utilizes that cancer cells release ctDNA
        into the circulation. ctDNA detected in blood drawn from a patient a few days after local
        removal of a tumor indicates that residual disease is present and further treatment, such as
        surgery, is needed.
  
        The purpose of this study is to investigate, whether analyses of ctDNA can correctly identify
        patients with residual disease after local removal of early CRC. If this identification
        proves accurate, many patients can be spared further surgery.
  KEY POINTS
  
          -  85% of patients receiving completion bowel resection after local removal of pT1 CRC are
             overtreated.
  
          -  ctDNA is a biomarker of residual cancer disease and could help identify those patients,
             where completion bowel resection is necessary, sparing those that are already cured.
  
        GOALS ● To explore ctDNA analysis for identification of the patient subgroup with residual
        disease after local excision of pT1 tumors and hence need for completion resection.
  
        PERSPECTIVES
  
        ● Practice-changing evidence for ctDNA-guided risk-stratification for pT1 CRCs after local
        excision, an important and well-recognized clinical dilemma in the management of CRC.
  
        PROJECT DESCRIPTION After the introduction of the nationwide screening program for CRC in
        Denmark, the number of very early-stage CRC cases (pT1) has increased. Many of these early
        cancers present macroscopically as polyps and are removed by local excision. Despite the
        early detection leading to improved prognosis, locally resected pT1 CRC presents a clinical
        dilemma, due to the small, but significant, risk of regional lymph node metastasis. This
        introduces the question: Was the patient cured by local resection alone? - or is segmental
        bowel resection (termed completion resection) required to remove metastatic regional lymph
        nodes and cure the patient? The present guideline for managing this clinical situation has
        led to massive overtreatment. Resection is recommended if the local excision was non-radical
        or if the histopathological assessment revealed ≥1 histopathological risk factor. However,
        only 15% of the patients receiving completion resection are diagnosed with metastatic lymph
        nodes. For the remaining 85%, the local excision was curative, and the completion resection
        was an overtreatment. Each year in Denmark, 130 colon and 40 rectal completion resections are
        performed. The complication rate after bowel resection is substantial. Following colonic
        resections 11% of patients suffer from surgical complications, 7% from medical complications,
        and 4% from a combination of both. For rectal cancer resection, the corresponding fractions
        are 20%, 5%, and 5%, respectively. The associated overall 30-day mortality is 1.3%, rising to
        1.5% after surgical complications and to 11% after medical or combined complications.
        Furthermore, many patients suffer from long-term or even chronic postoperative morbidities
        and late organ effects such as pain, bowel obstruction, and hernia formation.
  
        This highlights the significant importance of accurately choosing patients who indeed require
        completion resection for a definite cure.
  
        In the current study the use of ctDNA will be explored for identification of the patient
        subgroup with residual disease after local excision of pT1 tumors and, hence, the need for
        completion resection.
  
        The hypotheses are (1) ctDNA can be used to identify patients with residual disease requiring
        completion resection and (2) patients without detectable ctDNA were cured by the local
        resection, and therefore can be spared completion resection.
  
        Investigators will conduct a prospective, observational feasibility study, assessing the
        association between pre-completion-resection ctDNA status and the presence of residual
        disease established by pathological evaluation of the resected specimen. A total of 67
        patients, who have undergone local resection of pT1 CRC and who are planned to receive a
        completion resection will be included. Blood samples will be collected before the completion
        resection. Tumor tissue will be obtained from the locally resected pT1 tumor.
  
        ctDNA analysis will be performed using the recently published whole genome sequencing-based
        MRDetect approach.
  
        Feasibility measures: 1) recruitment of >30 patients every 6 months, 2) a ctDNA positivity
        rate ≥70%, and 3) accuracy of ctDNA status predicting lymph node status. Using the pathology
        evaluation of the completion resection specimen as gold standard.
  
        If the performance criteria are met, the study will be transitioned into an open-label 1:1
        randomized trial comparing the effect of ctDNA-guided patient selection for completion
        resection to current practice, which is completion resection to all. If the performance
        criteria are not met, the method will be re-evaluated to optimize sensitivity.
  observational model: Cohort
  time perspective: Prospective
  measure: ctDNA analysis
  time frame: After recruitment of the last patient, we expect that ctDNA analyses can be performed within 6 months
  description: Blood samples will be categorized as either ctDNA positive or negative
  measure: Pathological evaluation of the resected specimen from the completion resection
  time frame: After recruitment of the last patient, these data will be available (expected in spring 2024)
  description: Evaluations will be used to group patients into residual and no residual disease after local resection
  measure: 30- and 90-day mortality related to the completion resection
  time frame: After recruitment of the last patient, these data will be extracted from the patient's medical records within 12 months
  description: Mortality data for secondary outcomes
  measure: Postoperative morbidities
  time frame: After recruitment of the last patient, these data will be extracted from the patient's medical records within 6 months
  description: Morbidity data for secondary outcomes
  Blood samples will be drawn prior to and around 14 days after completion resection.
  
        Blood draw: 80 mL - 7 x EDTA tubes, 1 x serum tube
  
        Formalin-fixed paraffin-embedded (FFPE) tissue from the local treatment will be obtained from
        the relevant Pathological departments, for the purpose of extracting DNA for mutational
        analysis.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mads F Klein, MD, PhD
  role: Principal Investigator
  affiliation: Copenhagen University Hospital at Herlev
  last name: Jeppe Kildsig, MD
  role: Principal Investigator
  affiliation: Copenhagen University Hospital at Herlev
  last name: Kåre A Gotschalck, MD, PhD
  role: Principal Investigator
  affiliation: Regional Hospital Horsens
  last name: Anne-Sofie Kannerup, MD, PhD
  role: Principal Investigator
  affiliation: Regional Hospital Randers
  last name: Lene H Iversen, MD, DMSc
  role: Principal Investigator
  affiliation: Aarhus University Hospital
  last name: Claus L Andersen, PhD
  phone: +45 7845 5319
  email: cla@clin.au.dk
  last name: Mads F Klein, MD, PhD
  email: mads.falk.klein@regionh.dk
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Denmark
  url: https://www.sundhed.dk/content/cms/81/4681_dccg-klinisk-temarapport-2018.pdf
  description: Danish Colorectal Cancer Group - 2018 Report on postoperative surgical complications (in Danish)
  citation: Zviran A, Schulman RC, Shah M, Hill STK, Deochand S, Khamnei CC, Maloney D, Patel K, Liao W, Widman AJ, Wong P, Callahan MK, Ha G, Reed S, Rotem D, Frederick D, Sharova T, Miao B, Kim T, Gydush G, Rhoades J, Huang KY, Omans ND, Bolan PO, Lipsky AH, Ang C, Malbari M, Spinelli CF, Kazancioglu S, Runnels AM, Fennessey S, Stolte C, Gaiti F, Inghirami GG, Adalsteinsson V, Houck-Loomis B, Ishii J, Wolchok JD, Boland G, Robine N, Altorki NK, Landau DA. Genome-wide cell-free DNA mutational integration enables ultra-sensitive cancer monitoring. Nat Med. 2020 Jul;26(7):1114-1124. doi: 10.1038/s41591-020-0915-3. Epub 2020 Jun 1.
  PMID: 32483360
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  sharing ipd: Undecided