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The Gastric Cancer Foundation: A Gastric Cancer Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01514045
First received: January 17, 2012
Last updated: January 30, 2015
Last verified: January 2015
History of Changes
  Purpose

The Gastric Cancer Registry will combine data acquired directly from patients with gastric cancer via an online questionnaire with genomic data obtained from 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; as well as explore the issues that effect the quality of life of these patients after diagnosis and treatment.


Condition
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: The Gastric Cancer Foundation: A Gastric Cancer Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Collect detailed clinical and epidemiological information on patients with gastric tumors [ Time Frame: A quality of life questionnaire will also be administered when patients first enroll in the registry and then every 6 months after for five years. Specimen collected once. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples with DNA Paraffin embedded tissue will be stored in the Stanford Tissue Bank for 100 years.
Estimated Enrollment: 1000
Study Start Date: April 2011
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Detailed Description:

Collect detailed clinical and epidemiological information on patients with gastric tumors via an online registry and a detailed patient questionnaire. Participants can opt in to contribute a blood sample and paraffin block samples from previous surgery.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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.
  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: NCT01514045

Contacts
Contact: Meredith Mills 650-724-5223 bluett@stanford.edu

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Meredith Mills    650-724-5223    bluett@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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01514045     History of Changes
Other Study ID Numbers: GI0005, SU-01172012-8987, 20285
Study First Received: January 17, 2012
Last Updated: January 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Quality of Life

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

ClinicalTrials.gov processed this record on February 27, 2015