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Permission to Collect Blood Over Time for Research

This study has been terminated.
(Accrual issues - Low Accrual)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00767234
First received: October 3, 2008
Last updated: July 6, 2016
Last verified: July 2016
  Purpose
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 ]

Biospecimen Retention:   Samples Without DNA
blood

Enrollment: 104
Study Start Date: August 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Observation
    Standard of Care
  Eligibility

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
Criteria

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 ClinicalTrials.gov identifier: NCT00767234

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

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00767234     History of Changes
Other Study ID Numbers: GI0003
GI0003 ( Other Identifier: Stanford University )
8502 ( Other Identifier: Stanford IRB )
Study First Received: October 3, 2008
Last Updated: July 6, 2016

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Adenocarcinoma
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

ClinicalTrials.gov processed this record on September 21, 2017