Early Onset and Familial Gastric Cancer Registry

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00582257

Collaborator

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

971

Enrollment

Locations

216

Duration (Months)

97.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Behavioral: questionnaires

Study Design

Study Type:

Observational

Actual Enrollment :

971 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Early Onset and Familial Gastric Cancer Registry

Study Start Date :

Dec 1, 2005

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	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.

Arm

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

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.

Outcome Measures

Primary Outcome Measures

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 [December 2010]

Secondary Outcome Measures

To determine the incidence of CDH1 germline mutations among individuals with early onset or familial gastric cancer and their relatives. [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. [December 2010]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California - Norris Cancer Hospital	Los Angeles	California	United States	90033
2	Memorial Sloan Kettering Cancer Center at Basking Ridge	Basking Ridge	New Jersey	United States	07920
3	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
4	Memorial Sloan Kettering Cancer Center at Commack	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
6	Queens Cancer Center of Queens Hospital	Jamaica	New York	United States	11432
7	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
8	Weill Cornell Medical Center	New York	New York	United States	10065
9	Memorial Sloan Kettering Cancer Center at Mercy Medical Center	Rockville Centre	New York	United States	11570
10	Obafemi Awolowo University Teaching Hospital	Ile-Ife		Nigeria