Early Onset and Familial Gastric Cancer Registry

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Obafemi Awolowo University Teaching Hospital, Ile-Ife, Nigeria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient/Relative Cohort:

Must meet one or more criteria below:

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

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.
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).

Treatment and study plan

Questionnaires

Behavioral

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.

Primary outcomes

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

Secondary outcomes

To determine the incidence of CDH1 germline mutations among individuals with early onset or familial gastric cancer and their relatives.

Time frame: 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

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

Registry information

Important dates

Study start: 2005
Primary completion: 2024
Study completion: 2024
First posted: Dec 28, 2007
Registry last updated: Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed