Permission to Collect Blood Over Time for Research

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Stanford University
Information provided by (Responsible Party):
Stanford University Identifier:
First received: October 3, 2008
Last updated: May 20, 2014
Last verified: May 2014
To determine whether biomarkers assessed in blood samples can be used to detect individuals at risk for developing blood clots or worsening of their underlying disease. The ultimate goal of the study is to identify key biomarkers derived from blood that are most characteristic and informative of individuals who will go on to develop a clotting complication.

Condition Intervention
Pancreatic Cancer
Gastrointestinal Neoplasms
Colon Rectal Cancer Adenocarcinoma
Esophageal Cancer
Gall Bladder Cancer
Gastric (Stomach) Cancer
Gastrooesophageal Cancer
Gastrointestinal Stromal Tumor (GIST)
Hepatobiliary Neoplasm
Liver Carcinoma
Gallbladder Carcinoma
Bile Duct Carcinoma
Carcinoma of the Large Intestine
Anal Cancer
Procedure: Observation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting DVT Risk in GI Cancer Patients Using Plasma Biomarkers

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Identify Biomarkers [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Estimated Enrollment: 345
Study Start Date: August 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Observation
    Standard of Care

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Active cancers of the GI tract

Inclusion Criteria:

  • Male or female, >= 18 years old. There are no ethnic restrictions.
  • Active cancers of the GI tract (gastroesophageal, colorectal, or pancreatic-biliary) that have completed TNM staging by the American Joint Committee on Cancer; stage III disease if diagnosed within 2 months and all stage IV disease
  • Ability to understand and the willingness to sign a written informed consent document.
  • Existing staging CT imaging study

Exclusion Criteria:

  • Life expectancy < 6 months
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • Known pregnancy or positive urine pregnancy test in pre-menopausal women
  • On anticoagulant therapy (heparin, warfarin, direct thrombin inhibitors)
  • No CT imaging studies, or contraindications to undergoing CT imaging
  • Existing or anticipated need for a tunneled central venous catheter
  • Clinic visitation to Stanford Cancer center for secondary consultation purposes only
  • Inability to give informed consent
  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 identifier: NCT00767234

United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Fizaa Ahmed    650-725-6409   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Sub-Investigator: Haruka Itakura, PhD         
Sub-Investigator: George Albert Fisher M.D. Ph.D.         
Sub-Investigator: Dr. Lawrence (Rusty) Hofmann MD         
Sub-Investigator: Lawrence L Leung         
Sub-Investigator: Shyam         
Sub-Investigator: Thomas Quertermous         
Principal Investigator: Philip Tsao         
Sponsors and Collaborators
Stanford University
Principal Investigator: Haruka Itakura Stanford University
  More Information

No publications provided

Responsible Party: Stanford University Identifier: NCT00767234     History of Changes
Other Study ID Numbers: GI0003  GI0003  8502 
Study First Received: October 3, 2008
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Ductal
Carcinoma, Hepatocellular
Colorectal Neoplasms
Digestive System Neoplasms
Esophageal Neoplasms
Gallbladder Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors
Pancreatic Neoplasms
Biliary Tract Diseases
Biliary Tract Neoplasms
Colonic Diseases
Digestive System Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Gallbladder Diseases
Gastrointestinal Diseases
Head and Neck Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue processed this record on February 08, 2016