<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/NCT03027427</url>
  </required_header>
  <id_info>
    <org_study_id>170044</org_study_id>
    <secondary_id>17-C-0044</secondary_id>
    <nct_id>NCT03027427</nct_id>
  </id_info>
  <brief_title>Prospective Evaluation and Molecular Profiling in People With Gastric Tumors</brief_title>
  <official_title>Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Certain stomach cancers are rare, but they have high mortality rates. Researchers want to&#xD;
      learn more about gastric (stomach) tumors. In this study, they want to collect data from&#xD;
      people who have stomach cancer or are at risk to get it. This data will be used to see if the&#xD;
      people can be in other studies.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To study tissue from stomach tumors and find people eligible for more studies on gastric&#xD;
      cancer.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Age greater than or equal to 2 years old who have or may have stomach cancer, lesions that&#xD;
      may be related to stomach cancer, or an inherited disorder that leads to stomach cancer.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with:&#xD;
&#xD;
      Medical history&#xD;
&#xD;
      Physical exam&#xD;
&#xD;
      Blood and urine tests&#xD;
&#xD;
      Heart tests&#xD;
&#xD;
      Scans or ultrasound.&#xD;
&#xD;
      For the scans, participants lie in a machine that takes pictures. For some scans, they will&#xD;
      swallow or be injected with a small amount of radioactive material. Special cameras will show&#xD;
      the material in the body.&#xD;
&#xD;
      Tumor sample taken with a needle or surgery&#xD;
&#xD;
      Some participants will have an endoscopy. A long, flexible tube with a camera will be&#xD;
      inserted through the mouth into the stomach. The tube will collect tissue from the stomach.&#xD;
&#xD;
      Some participants may have follow-up visits. Some may be invited to join other studies.&#xD;
      Others will be contacted by phone to see how they are doing.&#xD;
&#xD;
      ...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
        -  Greater than 90% of gastric tumors are of epithelial origin and are classified as&#xD;
           adenocarcinomas; the remainders include GIST, carcinoid and lymphoma&#xD;
&#xD;
        -  Gastric adenocarcinoma is rare in the United States (incidence 7.4 per 100,000)&#xD;
&#xD;
        -  Mortality rates are high with an estimated 5-year overall survival of 25% - 30%&#xD;
&#xD;
        -  Up to 3% of gastric adenocarcinomas occur as part of a heritable cancer syndrome&#xD;
&#xD;
        -  Molecular sub-classification of gastric adenocarcinomas has been reported, however&#xD;
           translation of these findings into clinical management of patients has yet to occur&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        -  To permit clinical and laboratory evaluation and molecular profiling of tumor tissue&#xD;
           from patients with gastric malignancies or non-invasive (neoplastic) conditions&#xD;
&#xD;
        -  Assess eligibility for enrollment in studies of gastric cancer conducted in the CCR&#xD;
&#xD;
        -  To allow long-term follow up of patients with gastric tumors, or heritable gastric&#xD;
           malignancy syndromes, to support clinical and preclinical research particularly related&#xD;
           to molecular alterations in gastric tumors and their response to therapy&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Patients with the following are eligible:&#xD;
&#xD;
        -  Malignant or non-invasive, neoplastic lesions of the stomach confirmed by histopathology&#xD;
           or cytopathology;&#xD;
&#xD;
        -  Suspicious lesion not yet confirmed, but considered likely related to the stomach&#xD;
           pending further evaluation;&#xD;
&#xD;
        -  Confirmed, deleterious germline mutation (including but not limited to HDGC, GAPPS)&#xD;
           known to predispose to gastric tumors;&#xD;
&#xD;
        -  Confirmed or suspicious heritable gastric malignancy disorder;&#xD;
&#xD;
        -  Clinically suspicious personal or family medical history of gastric cancer or gastric&#xD;
           cancer syndrome that warrants genetics evaluation.&#xD;
&#xD;
        -  Age greater than or equal to 2 years.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  This protocol is designed to facilitate clinical evaluation, molecular tumor profiling,&#xD;
           and long-term follow up of patients with gastric tumors&#xD;
&#xD;
        -  Patients will be screened and clinical evaluation performed to determine eligibility for&#xD;
           other CCR trials for gastric tumors&#xD;
&#xD;
        -  No investigational treatment will be administered and no procedures will be done for&#xD;
           only research purposes on this protocol.&#xD;
&#xD;
        -  It is anticipated that the protocol will enroll a maximum of 250 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2030</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Long-term follow up to support clinical and preclinical research</measure>
    <time_frame>follow up</time_frame>
    <description>long-term follow up of patients with gastric tumors, or heritable gastric malignancy syndromes screened on this study, to support clinical and preclinical research particularly related to molecular alterations in gastric tumors and their response to therapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of eligibility</measure>
    <time_frame>at initial visit</time_frame>
    <description>determination of eligibility for enrollment in studies of gastric cancer conducted in the CCR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical and laboratory evaluation and molecular profiling of tumor tissue</measure>
    <time_frame>at initial visit and as clinically indicated</time_frame>
    <description>Tissue samples collected to permit clinical and laboratory evaluation and molecular profiling of tumor tissue from patients with gastric malignancies or non-invasive (neoplastic) conditions</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Stomach Neoplasms</condition>
  <condition>Stomach Cancer</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Patients with the following are eligible:&#xD;
&#xD;
               -  Malignant or non-invasive, neoplastic lesions of the stomach confirmed by&#xD;
                  histopathology or cytopathology in a CLIA-certified laboratory&#xD;
&#xD;
        OR&#xD;
&#xD;
        --Suspicious lesions not yet confirmed, but considered likely to be related to the stomach&#xD;
        pending further evaluation&#xD;
&#xD;
        OR&#xD;
&#xD;
          -  Confirmed, deleterious germline mutation (including but not limited to HDGC, GAPPS)&#xD;
             known to predispose to gastric tumors;&#xD;
&#xD;
          -  Confirmed or suspicious heritable gastric malignancy disorder;&#xD;
&#xD;
          -  Clinically suspicious personal or family medical history of gastric cancer or gastric&#xD;
             cancer syndrome that warrants genetics evaluation.&#xD;
&#xD;
               -  Patients must have an ECOG performance score of 0-2.&#xD;
&#xD;
               -  Age greater than or equal to 2 years. Note: Patients greater than or equal to 2&#xD;
                  and less than or equal to 18 years of age may only participate in research sample&#xD;
                  collection if the tissue acquisition is performed during a clinically indicated&#xD;
                  surgical procedure, and the sampling of tissue, blood and urine does not add risk&#xD;
                  to the clinically indicated procedures.&#xD;
&#xD;
               -  The patient is a candidate for the clinically indicated medical evaluations that&#xD;
                  are being offered&#xD;
&#xD;
               -  Ability of subject, their parents/guardians or legally authorized representative&#xD;
                  (LAR) to understand and must be willing to sign a written informed consent&#xD;
                  document.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        Candidates who do not meet the inclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy L Davis, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cathleen E Hannah</last_name>
    <phone>(240) 409-8860</phone>
    <email>foregut@mail.nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jeremy L Davis, M.D.</last_name>
    <phone>(240) 858-3731</phone>
    <email>jeremy.davis@nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact National Cancer Institute Referral Office</last_name>
      <phone>888-624-1937</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-C-0044.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Wang K, Yuen ST, Xu J, Lee SP, Yan HH, Shi ST, Siu HC, Deng S, Chu KM, Law S, Chan KH, Chan AS, Tsui WY, Ho SL, Chan AK, Man JL, Foglizzo V, Ng MK, Chan AS, Ching YP, Cheng GH, Xie T, Fernandez J, Li VS, Clevers H, Rejto PA, Mao M, Leung SY. Whole-genome sequencing and comprehensive molecular profiling identify new driver mutations in gastric cancer. Nat Genet. 2014 Jun;46(6):573-82. doi: 10.1038/ng.2983. Epub 2014 May 11.</citation>
    <PMID>24816253</PMID>
  </reference>
  <reference>
    <citation>Cristescu R, Lee J, Nebozhyn M, Kim KM, Ting JC, Wong SS, Liu J, Yue YG, Wang J, Yu K, Ye XS, Do IG, Liu S, Gong L, Fu J, Jin JG, Choi MG, Sohn TS, Lee JH, Bae JM, Kim ST, Park SH, Sohn I, Jung SH, Tan P, Chen R, Hardwick J, Kang WK, Ayers M, Hongyue D, Reinhard C, Loboda A, Kim S, Aggarwal A. Molecular analysis of gastric cancer identifies subtypes associated with distinct clinical outcomes. Nat Med. 2015 May;21(5):449-56. doi: 10.1038/nm.3850. Epub 2015 Apr 20.</citation>
    <PMID>25894828</PMID>
  </reference>
  <reference>
    <citation>Cancer Genome Atlas Research Network. Comprehensive molecular characterization of gastric adenocarcinoma. Nature. 2014 Sep 11;513(7517):202-9. doi: 10.1038/nature13480. Epub 2014 Jul 23.</citation>
    <PMID>25079317</PMID>
  </reference>
  <verification_date>September 13, 2023</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 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>
  <keyword>Screening</keyword>
  <keyword>Heritable Gastric Malignancy</keyword>
  <keyword>Molecular Profiling</keyword>
  <keyword>Molecular Alterations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.</ipd_time_frame>
    <ipd_access_criteria>Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.</ipd_access_criteria>
  </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/NCT03027427
org study id: 170044
secondary id: 17-C-0044
nct id: NCT03027427
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Certain stomach cancers are rare, but they have high mortality rates. Researchers want to
      learn more about gastric (stomach) tumors. In this study, they want to collect data from
      people who have stomach cancer or are at risk to get it. This data will be used to see if the
      people can be in other studies.

      Objective:

      To study tissue from stomach tumors and find people eligible for more studies on gastric
      cancer.

      Eligibility:

      Age greater than or equal to 2 years old who have or may have stomach cancer, lesions that
      may be related to stomach cancer, or an inherited disorder that leads to stomach cancer.

      Design:

      Participants will be screened with:

      Medical history

      Physical exam

      Blood and urine tests

      Heart tests

      Scans or ultrasound.

      For the scans, participants lie in a machine that takes pictures. For some scans, they will
      swallow or be injected with a small amount of radioactive material. Special cameras will show
      the material in the body.

      Tumor sample taken with a needle or surgery

      Some participants will have an endoscopy. A long, flexible tube with a camera will be
      inserted through the mouth into the stomach. The tube will collect tissue from the stomach.

      Some participants may have follow-up visits. Some may be invited to join other studies.
      Others will be contacted by phone to see how they are doing.

      ...
Background:

        -  Greater than 90% of gastric tumors are of epithelial origin and are classified as
           adenocarcinomas; the remainders include GIST, carcinoid and lymphoma

        -  Gastric adenocarcinoma is rare in the United States (incidence 7.4 per 100,000)

        -  Mortality rates are high with an estimated 5-year overall survival of 25% - 30%

        -  Up to 3% of gastric adenocarcinomas occur as part of a heritable cancer syndrome

        -  Molecular sub-classification of gastric adenocarcinomas has been reported, however
           translation of these findings into clinical management of patients has yet to occur

      Objectives:

        -  To permit clinical and laboratory evaluation and molecular profiling of tumor tissue
           from patients with gastric malignancies or non-invasive (neoplastic) conditions

        -  Assess eligibility for enrollment in studies of gastric cancer conducted in the CCR

        -  To allow long-term follow up of patients with gastric tumors, or heritable gastric
           malignancy syndromes, to support clinical and preclinical research particularly related
           to molecular alterations in gastric tumors and their response to therapy

      Eligibility:

      Patients with the following are eligible:

        -  Malignant or non-invasive, neoplastic lesions of the stomach confirmed by histopathology
           or cytopathology;

        -  Suspicious lesion not yet confirmed, but considered likely related to the stomach
           pending further evaluation;

        -  Confirmed, deleterious germline mutation (including but not limited to HDGC, GAPPS)
           known to predispose to gastric tumors;

        -  Confirmed or suspicious heritable gastric malignancy disorder;

        -  Clinically suspicious personal or family medical history of gastric cancer or gastric
           cancer syndrome that warrants genetics evaluation.

        -  Age greater than or equal to 2 years.

      Design:

        -  This protocol is designed to facilitate clinical evaluation, molecular tumor profiling,
           and long-term follow up of patients with gastric tumors

        -  Patients will be screened and clinical evaluation performed to determine eligibility for
           other CCR trials for gastric tumors

        -  No investigational treatment will be administered and no procedures will be done for
           only research purposes on this protocol.

        -  It is anticipated that the protocol will enroll a maximum of 250 patients.
observational model: Case-Only
time perspective: Prospective
measure: Long-term follow up to support clinical and preclinical research
time frame: follow up
description: long-term follow up of patients with gastric tumors, or heritable gastric malignancy syndromes screened on this study, to support clinical and preclinical research particularly related to molecular alterations in gastric tumors and their response to therapy
measure: Determination of eligibility
time frame: at initial visit
description: determination of eligibility for enrollment in studies of gastric cancer conducted in the CCR
measure: Clinical and laboratory evaluation and molecular profiling of tumor tissue
time frame: at initial visit and as clinically indicated
description: Tissue samples collected to permit clinical and laboratory evaluation and molecular profiling of tumor tissue from patients with gastric malignancies or non-invasive (neoplastic) conditions
arm group label: Patients
description: Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Jeremy L Davis, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
last name: Cathleen E Hannah
phone: (240) 409-8860
email: foregut@mail.nih.gov
last name: Jeremy L Davis, M.D.
phone: (240) 858-3731
email: jeremy.davis@nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-C-0044.html
description: NIH Clinical Center Detailed Web Page
citation: Wang K, Yuen ST, Xu J, Lee SP, Yan HH, Shi ST, Siu HC, Deng S, Chu KM, Law S, Chan KH, Chan AS, Tsui WY, Ho SL, Chan AK, Man JL, Foglizzo V, Ng MK, Chan AS, Ching YP, Cheng GH, Xie T, Fernandez J, Li VS, Clevers H, Rejto PA, Mao M, Leung SY. Whole-genome sequencing and comprehensive molecular profiling identify new driver mutations in gastric cancer. Nat Genet. 2014 Jun;46(6):573-82. doi: 10.1038/ng.2983. Epub 2014 May 11.
PMID: 24816253
citation: Cristescu R, Lee J, Nebozhyn M, Kim KM, Ting JC, Wong SS, Liu J, Yue YG, Wang J, Yu K, Ye XS, Do IG, Liu S, Gong L, Fu J, Jin JG, Choi MG, Sohn TS, Lee JH, Bae JM, Kim ST, Park SH, Sohn I, Jung SH, Tan P, Chen R, Hardwick J, Kang WK, Ayers M, Hongyue D, Reinhard C, Loboda A, Kim S, Aggarwal A. Molecular analysis of gastric cancer identifies subtypes associated with distinct clinical outcomes. Nat Med. 2015 May;21(5):449-56. doi: 10.1038/nm.3850. Epub 2015 Apr 20.
PMID: 25894828
citation: Cancer Genome Atlas Research Network. Comprehensive molecular characterization of gastric adenocarcinoma. Nature. 2014 Sep 11;513(7517):202-9. doi: 10.1038/nature13480. Epub 2014 Jul 23.
PMID: 25079317
responsible party type: Sponsor
mesh term: Stomach Neoplasms
sharing ipd: Yes
ipd description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
ipd access criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.