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Permission to Collect Blood Over Time for Research

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. Read our disclaimer for details. Identifier: NCT00767234
Recruitment Status : Terminated (Accrual issues - Low Accrual)
First Posted : October 7, 2008
Last Update Posted : July 11, 2016
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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 or disease Intervention/treatment
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
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting DVT Risk in GI Cancer Patients Using Plasma Biomarkers
Study Start Date : August 2008
Primary Completion Date : October 2011
Study Completion Date : October 2011

Intervention Details:
    Procedure: Observation
    Standard of Care

Primary Outcome Measures :
  1. Identify Biomarkers [ Time Frame: 3 years ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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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
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

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 identifier (NCT number): NCT00767234

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Haruka Itakura Stanford University

Responsible Party: Stanford University Identifier: NCT00767234     History of Changes
Other Study ID Numbers: GI0003
GI0003 ( Other Identifier: Stanford University )
8502 ( Other Identifier: Stanford IRB )
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Pancreatic Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Gastrointestinal Stromal Tumors
Anus Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Carcinoma, Hepatocellular
Carcinoma, Ductal
Gallbladder Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Head and Neck Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue