Early Onset and Familial Gastric Cancer Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 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: April 26, 2016
Last verified: April 2016
  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 2017
Estimated Primary Completion Date: December 2017 (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) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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).
  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      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: David Kelsen, MD    212-639-8470      
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 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 Center Withdrawn
Jerusalem, Israel, 91031
Nigeria
Obafemi Awolowo University Teaching Hospital Completed
Ile-Ife, Nigeria
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:
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: April 26, 2016
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 25, 2016