Prospective Evaluation and Molecular Profiling in People With Gastric Tumors

Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors

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.

...

Study Overview

• Status: Recruiting
• Conditions: Stomach Neoplasms; Stomach Cancer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Jeremy L Davis, M.D.; Phone Number: (240) 858-3731; Email: jeremy.davis@nih.gov
• Study Contact Backup: Name: Cathleen E Hannah, C.R.N.P.; Phone Number: (240) 858-7006; Email: foregut@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office; Phone Number: 888-624-1937

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder

Description

• INCLUSION CRITERIA:

• Patients with the following are eligible:

  • Malignant or non-invasive, neoplastic lesions of the stomach confirmed by histopathology or cytopathology in a CLIA-certified laboratory

OR

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

OR

• 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.

  • Patients must have an ECOG performance score of 0-2.
  • Age greater than or equal to 2 years. Note: Patients greater than or equal to 2 and less than or equal to 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood and urine does not add risk to the clinically indicated procedures.
  • The patient is a candidate for the clinically indicated medical evaluations that are being offered
  • Ability of subject, their parents/guardians or legally authorized representative (LAR) to understand and must be willing to sign a written informed consent document.

EXCLUSION CRITERIA:

Candidates who do not meet the inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients; Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term follow up to support clinical and preclinical research	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	follow up
Determination of eligibility	determination of eligibility for enrollment in studies of gastric cancer conducted in the CCR	at initial visit
Clinical and laboratory evaluation and molecular profiling of tumor tissue	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	at initial visit and as clinically indicated

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jeremy L Davis, M.D., National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimated): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 8, 2024

More Information

Terms related to this study

• Keywords: Screening; Molecular Profiling; Heritable Gastric Malignancy; Molecular Alterations
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 170044; 17-C-0044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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 Sharing 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 Sharing 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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No