- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00582257
Early Onset and Familial Gastric Cancer Registry
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ile-Ife, Nigeria
- Obafemi Awolowo University Teaching Hospital
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California
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Los Angeles, California, United States, 90033
- University of Southern California - Norris Cancer Hospital
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Cancer Center at Basking Ridge
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center at Commack
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
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Jamaica, New York, United States, 11432
- Queens Cancer Center of Queens Hospital
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10065
- Weill Cornell Medical Center
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Rockville Centre, New York, United States, 11570
- Memorial Sloan Kettering Cancer Center at Mercy Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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. |
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:
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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. |
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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December 2010
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To determine the incidence of CDH1 germline mutations among individuals with early onset or familial gastric cancer and their relatives.
Time Frame: December 2010
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December 2010
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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
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December 2010
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Kelsen, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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