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The Gastric Cancer Foundation: A Gastric Cancer Registry

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ClinicalTrials.gov Identifier: NCT01514045
Recruitment Status : Recruiting
First Posted : January 20, 2012
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
The Gastric Cancer Registry will combine data acquired directly from patients with gastric cancer; with a family history of gastric cancer in a first or second degree relative; or persons with a known germline mutation in their CDH1 (E-Cadherin) gene via an online questionnaire with genomic data obtained from saliva, blood and tissue samples. The purpose of this registry is to gain better understanding of the causes of gastric cancer, both environmental and genetic; whether certain genomic data can predict outcomes of treatment and survival.

Condition or disease
Gastric Cancer

Detailed Description:
Collect detailed clinical and epidemiological information on eligible patients via an online registry and a detailed patient questionnaire. Participants can opt in to contribute a blood or saliva sample and paraffin block samples from a previous gastric surgery.

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: The Gastric Cancer Foundation: A Gastric Cancer Registry
Study Start Date : April 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Collect detailed clinical and epidemiological information on patients with gastric cancer; with a family history of gastric cancer in a first or second degree relative; or persons with a known germline mutation in their CDH1 (E-Cadherin) gene [ Time Frame: 1 day ]

Biospecimen Retention:   Samples With DNA
Blood samples with DNA Paraffin embedded tissue will be stored in the Stanford Tissue Bank for 100 years.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be identified for recruitment either by the individual's treating physician or through information about the registry on the Gastric Cancer Fund website. Potential participants will be directed to the URL for the gastric cancer registry and asked to complete a brief registration form which will include eligibility questions.
Criteria

Inclusion Criteria:

  1. Patients are eligible if they have a histologically proven gastric tumor including gastroesophageal tumors; OR they have a family history of gastric cancer in a first or second degree relative; OR persons with a known germline mutation in their CDH1 (E-Cadherin) gene.
  2. 18 years of age or older
  3. Adequate English proficiency to complete online consent and questionnaire.

Exclusion Criteria:

  1. Under 18 years of age
  2. No history of gastric cancer or gastric cancer in a family member or a known germline mutation in their CDH1 gene.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514045


Contacts
Contact: Alison Almeda 650-497-3619 aalmeda@stanford.edu

Locations
United States, California
Stanford University, School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Alison Almeda    650-497-3619    aalmeda@stanford.edu   
Principal Investigator: James M Ford, MD         
Sub-Investigator: Hanlee P Ji, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: James M Ford, MD Stanford University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01514045     History of Changes
Other Study ID Numbers: GI0005
SU-01172012-8987 ( Other Identifier: Stanford University )
20285 ( Other Identifier: Stanford University )
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018

Keywords provided by Stanford University:
Quality of Life

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