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Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma

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ClinicalTrials.gov Identifier: NCT01048281
Recruitment Status : Recruiting
First Posted : January 13, 2010
Last Update Posted : July 14, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Our research of the biology of upper gastrointestinal cancers involves the study of tissue samples and cells from biopsies of persons with gastric or esophageal cancer or blood samples from upper gastrointestinal cancer patients and persons at high inherited risk for these cancers. We hope to learn the role genes and proteins play in the development of gastric and esophageal cancer.

Condition or disease Intervention/treatment
Stomach Cancer Gastro-Esophageal(GE) Junction Cancer Gastric (Stomach) Cancer Esophageal Cancer Gastrointestinal Stromal Tumor (GIST) Procedure: Blood draw Procedure: Tissue tumor biopsy

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

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
Study Start Date : August 2002
Estimated Primary Completion Date : January 2099
Estimated Study Completion Date : January 2099

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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


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. p53 activity by routine pathologic analysis [ Time Frame: time of collection ]
  2. NER activity by routine pathologic analysis [ Time Frame: time of collection ]

Biospecimen Retention:   Samples With DNA
blood, tumor

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

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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
Adults with gastric or esophageal cancer
Criteria

Inclusion Criteria:1. Over 18 2. Diagnosed with gastric or esophageal cancer OR at an increased hereditary risk for upper GI cancer

Exclusion Criteria:1. Under 18 2. No family or personal history of gastric or esophageal cancer

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): NCT01048281


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

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Meredith Mills    650-724-5223    bluett@stanford.edu   
Principal Investigator: James M Ford         
Sub-Investigator: Hanlee P. Ji         
Sub-Investigator: Vandana Bhardwaj Sharma         
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
Principal Investigator: James M Ford 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: NCT01048281     History of Changes
Other Study ID Numbers: GIUPR0001
76274 ( Other Identifier: Stanford University Alternate IRB Approval Number )
CA109190 ( Other Identifier: NIH )
SU-11022007-787 ( Other Identifier: Stanford University )
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Stromal Tumors
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
 Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Stomach Diseases