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Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma

This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01048281
First received: January 11, 2010
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

To develop research programs and to characterize molecular & cellular biology of tumor cells in upper cancers. The researchers plan to use molecular diagnostic information obtained from studying upper GI tumor tissues to develop new treatment regimens in patients with these cancers.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • p53 activity by routine pathologic analysis [ Time Frame: time of collection ] [ Designated as safety issue: No ]
  • NER activity by routine pathologic analysis [ Time Frame: time of collection ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood, tumor


Estimated Enrollment: 100
Study Start Date: August 2002
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01048281     History of Changes
Other Study ID Numbers: GIUPR0001, 76274, CA109190, SU-11022007-787
Study First Received: January 11, 2010
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Esophageal Diseases
Esophageal Neoplasms
Stomach Neoplasms
Rectal Neoplasms
Pancreatic Neoplasms
Duodenal Neoplasms
Bile Duct Neoplasms
Gastrointestinal Stromal Tumors
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Stomach Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Duodenal Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013