Early Onset and Familial Gastric Cancer Registry

October 1, 2024 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to establish a gastric cancer registry. A registry is a database of information. With the registry, we can learn more about the genetic causes of gastric cancer in order to develop better methods of early diagnosis, prevention, and treatment of gastric cancers. As part of this study, you will be asked to join a registry of families who are affected with various forms of gastric cancer. These registries are important because they may help physicians better manage gastric cancer now and in the future. Participating in the Early Onset and Familial Gastric Cancer Registry can also be educational for families, since it will provide important information to patients, families, and physicians. All of this will help to further our understanding of genetic causes of gastric cancer and eventually, help determine better ways to diagnose, treat, and survey patients with gastric cancer and people who may have a higher risk for gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

971

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
      • Ile-Ife, Nigeria
        • Obafemi Awolowo University Teaching Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California - Norris Cancer Hospital
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Cancer Center at Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center at Commack
      • Jamaica, New York, United States, 11432
        • Queens Cancer Center of Queens Hospital
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Weill Cornell Medical Center
      • Rockville Centre, New York, United States, 11570
        • Memorial Sloan Kettering Cancer Center at Mercy Medical Center
      • West Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK or collaborating centers. If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participation and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.

Description

Inclusion Criteria:

Patient/Relative Cohort:

Must meet one or more criteria below:

  1. A person with a diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed at the treating institution.

  2. A person without gastric or GEJ adenocarcinoma who has or had a first degree relative eligible for a High Risk Genetic sub-group (EOGC/FGC).

    1. Early Onset Gastric Cancer - diagnosis of gastric cancer before the age of 50 without a family history of the disease.
    2. Familial Gastric Cancer - having a family history of gastric cancer as defined as one first degree relative or 2 second degree relatives.
  3. A person without gastric or GEJ adenocarcinoma who has a personal family history of a genetic mutation associated with the development of gastric or GEJ adenocarcinoma (i.e. family history of CDH1 mutation).

II. Must be willing to provide a blood sample for germline DNA. These individuals will sign the "Patient/Relative Consent". Following enrollment, we will assign individuals to the appropriate High Genetic Risk or Low Genetic Risk groups based on the age of diagnosis and their family history.

Subject Exclusion Criteria

Patients are ineligible for the study if they:

  • Have any condition, which in the opinion of the primary MSK clinician or investigators precludes their ability to provide informed consent.
  • Relatives of patients that are not eligible for the High Genetic Risk Cohorts who are less than 18 years of age are excluded.
  • Relatives of patients eligible for the High Genetic Risk Cohorts who do not have a proband available to join the study are excluded. (Unless there is a known CDH1 mutation in the family).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High Genetic Risk:

Early Onset Gastric Cancer - diagnosis of gastric cancer before the age of 50 without a family history of the disease.

Familial Gastric Cancer - having a family history of gastric cancer as defined as one first degree relative or 2 second degree relatives.

Relative - Relatives of participants eligible for the High Genetic Risk Cohort will be eligible for participation. These relatives may also be at high risk of developing gastric cancer. These individuals will fall under the Cancer Cohort. Eligible relatives will be defined as someone having a relative who meets criteria for either the Early Onset Cancer Cohort or the Familial Gastric Cancer Cohort, or having a family history of a genetic mutation known to be associated with gastric cancer.
Behavioral: questionnaires
Participation in the registry will consist of adequately completing the family history questionnaire (one per family) the gastric cancer risk factor questionnaire and providing a blood sample for future correlative studies. Registry participants (both Patient/Relative and Control cohorts) will be required to submit tissue (both normal and/or tumor) to create a Tissue and DNA repository. Select participants will be invited to undergo Genetic Counseling, eg. those participants who meet clinical criteria for HDGC.
Other Names:
  • At outside centers, recruitment procedures are similar to the procedures at
  • MSK with the following two exceptions: Due to practice patterns, it may not
  • be feasible to obtain "Control Cohort" patients. Collaborating sites may
  • participate in the study without opening a "Control Cohort" after discussion
  • with the study PI. Phone consenting will only be done at MSKCC.
Low Genetic Risk: Closed to Accrual

Sporadic Gastric Cancer - gastric cancer that appears to have occurred by random or sporadic mutation. Specifically, a patient with gastric cancer not eligible for either High Genetic Risk cohort.

Control (closed to accrual) - A participant that is not a blood relative of a patient or relative participant, without gastric cancer and without a family history of a CDH1 gene mutation. Select MSK participants with Hereditary Diffuse Gastric Cancer with identified CDH1 germline genetic mutation will be invited by MSKCC only to complete the onetime Pre-implantation Genetic Diagnosis (HDGC PGD) survey. These patients may be verbally consented over the telephone.
Behavioral: questionnaires
Participation in the registry will consist of adequately completing the family history questionnaire (one per family) the gastric cancer risk factor questionnaire and providing a blood sample for future correlative studies. Registry participants (both Patient/Relative and Control cohorts) will be required to submit tissue (both normal and/or tumor) to create a Tissue and DNA repository. Select participants will be invited to undergo Genetic Counseling, eg. those participants who meet clinical criteria for HDGC.
Other Names:
  • At outside centers, recruitment procedures are similar to the procedures at
  • MSK with the following two exceptions: Due to practice patterns, it may not
  • be feasible to obtain "Control Cohort" patients. Collaborating sites may
  • participate in the study without opening a "Control Cohort" after discussion
  • with the study PI. Phone consenting will only be done at MSKCC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Create registry of families w/ early onset & familial gastric cancer for analysis of risk factors, family history and unidentified susceptibility genes. Create cohorts of pts w/ low genetic risk for the development of gastric cancer
Time Frame: December 2010
December 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the incidence of CDH1 germline mutations among individuals with early onset or familial gastric cancer and their relatives.
Time Frame: December 2010
December 2010
To determine the gastric pathology evident from a single baseline endoscopic screen of unaffected first-degree relatives of a patient with EOGC or FGC.
Time Frame: December 2010
December 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

University of Southern California
Weill Medical College of Cornell University
Obafemi Awolowo University Teaching Hospital
Shaare Zedek Medical Center
Queens Health Network

Investigators

  • Principal Investigator: David Kelsen, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2005

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimated)

December 28, 2007

Study Record Updates

Last Update Posted (Actual)

October 3, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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