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The Gastric Cancer Foundation: A Gastric Cancer Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01514045
Recruitment Status : Recruiting
First Posted : January 20, 2012
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date January 17, 2012
First Posted Date January 20, 2012
Last Update Posted Date February 24, 2023
Study Start Date April 2011
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2018)		 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 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Gastric Cancer Foundation: A Gastric Cancer Registry
Official Title The Gastric Cancer Foundation: A Gastric Cancer Registry
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.
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 Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples with DNA Paraffin embedded tissue will be stored in the Stanford Tissue Bank for 100 years.
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.
Condition Gastric Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 6, 2016)		 500
Original Estimated Enrollment
 (submitted: January 17, 2012)		 1000
Estimated Study Completion Date December 2025
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility 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. Spanish-language proficiency as an alternative to English-language proficiency.

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Alison Almeda 650-497-3619 GCRegistry@stanford.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01514045
Other Study ID Numbers IRB-20285
SU-01172012-8987 ( Other Identifier: Stanford University )
GI0005 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Stanford University
Original Responsible Party Same as current
Current Study Sponsor Stanford University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Hanlee P Ji, MD Stanford University
PRS Account Stanford University
Verification Date February 2023