Early Onset and Familial Gastric Cancer Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Weill Medical College of Cornell University
Queens Health Network
University of Southern California
Shaare Zedek Medical Center
Obafemi Awolowo University Teaching Hospital
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582257
First received: December 21, 2007
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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 Intervention
Gastric Cancer
Behavioral: questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Onset and Familial Gastric Cancer Registry

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

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 [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the incidence of CDH1 germline mutations among individuals with early onset or familial gastric cancer and their relatives. [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Germline DNA and Tissue


Estimated Enrollment: 2500
Study Start Date: December 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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) and the gastric cancer risk factor questionnaire. Registry participants (both Patient/Relative and Control cohorts) will also be invited to submit germline DNA and 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. Relatives of High Genetic Risk cohort participants who undergo a clinical upper endoscopy will be asked to submit the results of that procedure to the database.
Other Names:
  • At outside centers, recruitment procedures are similar to the procedures at
  • MSKCC 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:

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 - 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 MSKCC 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) and the gastric cancer risk factor questionnaire. Registry participants (both Patient/Relative and Control cohorts) will also be invited to submit germline DNA and 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. Relatives of High Genetic Risk cohort participants who undergo a clinical upper endoscopy will be asked to submit the results of that procedure to the database.
Other Names:
  • At outside centers, recruitment procedures are similar to the procedures at
  • MSKCC 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.

Detailed Description:

On a global basis, cancer of the stomach is the third most prevalent malignancy, with 947,000 expected new cases in 2000, and the second leading cancer cause of death (734,000 deaths annually). In the United States in 2003, approximately 22,400 cases of gastric cancer will be diagnosed, and 12,100 patients will die from this disease1. The prognosis of this disease is poor with 5-year relative survival rate of less than 20% for advanced disease. The etiology of gastric cancer is attributable to both environmental and hereditary factors. In the subset of patients with early onset disease and in particular among familial forms of this disease, inherited susceptibility appears to play a dominant role. No single mutation has been identified as responsible for early onset gastric cancer. Recent evidence has emerged supporting the role of germline mutations in the E-cadherin gene (CDH1) as conferring increased susceptibility to early onset diffuse type gastric cancer and better understanding of other genes that predispose to gastric cancer tumorigenesis is anticipated in the next several years2, 3. The primary purpose of this protocol is to establish a prospective registry with detailed family history, gastric cancer risk factors, germline DNA, and matched tumor and normal tissue for patients with early onset or familial gastric cancer and their at-risk relatives. With this aim in mind, we have amended the registry to include populations who are at low risk for germline etiology for the development of gastric cancer. This includes a cohort of patients with gastric cancer who appear to have developed the disease sporadically, as well as a cohort of control patients without gastric cancer. Secondary objectives are 1) To measure the incidence of germline mutations in CDH1 among "early onset" and "familial" gastric cancer patients and their relatives to determine the importance of this variant in gastric cancer susceptibility and 2) To measure the prevalence of abnormal gastric pathology among the cancer-free relatives of patients with "early onset" and "familial" gastric cancer. In this research protocol, early onset gastric cancer (EOGC) is defined as disease with age of onset before 50 that arises in the absence of family history of gastric cancer or known hereditary cancer syndrome. Familial gastric cancer (FGC) is defined as disease that occurs among individuals with at least one affected first degree relative or two or more affected second degree relatives.Patients eligible for the "sporadic" cohort are those not eligible for the EOGC or FGC. We will also establish a "low risk" cohort for comparison. Patients eligible for the "low risk" cohort are those not eligible for the EOGC or FGC. Study participants will fill out a questionnaire on their family history and on their gastric cancer risk factors. Participants will be invited to provide a sample of germline DNA for future genetic studies. Select high risk individuals, for example those that meet criteria for Diffuse Hereditary Gastric Cancer(DHGC), will be invited to participate in genetic counseling which is required prior to evaluation for CDH1 gene mutations. Select MSKCC participants who have Hereditary Diffuse Gastric Cancer syndrome with identified CDH1 germline genetic mutation may be invited by MSKCC only to complete a Pre-implantation Genetic Diagnosis (PGD) survey. In addition, participants will be invited to provide tissue (tumor and normal) where available, both fresh frozen and paraffin-embedded if possible. At risk relatives of patients with EOGC/FGC will also be invited for a single upper endoscopy screening test. At select sites, at risk relatives of patients with EOGC/FGC will also be invited for a single upper endoscopy screening test. The Early Onset/Familial Gastric Cancer Registry will serve as a source of clinical and pathological material that can be used to identify future genetic abnormalities that may or may not predispose the development of gastric cancer in these high-risk families and will help define a cohort for participation in future chemoprevention/screening studies. Moreover, it will ensure that there is a coherent unified approach for management of this rare group of patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  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).

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.

Control Cohort

Must meet all criteria below:

  1. Does not have gastric cancer.
  2. Not a blood relative of patient or relative participants.
  3. No family history of a mutation in the CDH1 gene.

These individuals will sign the "Control consent". Note: A participant's genetic risk group is subject to change due to change in their diagnosis, family history, or genetic test results.

Subject Exclusion Criteria

Patients are ineligible for the study if they:

  • Have any condition, which in the opinion of the primary MSKCC 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).
  • Control participants who are less than 18 years of age are excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582257

Contacts
Contact: David Kelsen, MD 646-888-4179
Contact: Manish Shah, MD 646-962-6200

Locations
United States, California
University of Southern California - Norris Cancer Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Heinz-Josef Lenz, MD    323-865-3955      
United States, New Jersey
Memorial Sloan-Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: David Kelsen, MD    212-639-8470      
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack Recruiting
Commack, New York, United States, 11725
Contact: David Kelsen, MD    212-639-8470      
Queens Cancer Center of Queens Hospital Recruiting
Jamaica, New York, United States, 11432
Contact: Margaret Kemeny, MD    718-883-4031      
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Manish A. Shah, MD    646-962-6200      
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: David Kelsen, MD    212-639-8470      
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11570
Contact: David Kelsen, MD    212-639-8470      
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: David Kelsen, MD    212-639-8470      
Israel
Sha'are Zedek Medical Recruiting
Jerusalem, Israel, 91031
Contact: Alberto Gabizon, MD    alberto@md.huji.ac.il      
Nigeria
Obafemi Awolowo University Teaching Hospital Recruiting
Ile-Ife, Nigeria
Contact: Olusegun Isaac Alatise, MD       segunalatishe@oau.edu.ng   
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
Queens Health Network
University of Southern California
Shaare Zedek Medical Center
Obafemi Awolowo University Teaching Hospital
Investigators
Principal Investigator: David Kelsen, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582257     History of Changes
Other Study ID Numbers: 05-118
Study First Received: December 21, 2007
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Gastric Cancer
Stomach Cancer
05-118

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 18, 2014