Permission to Collect Blood Over Time for Research
This study is currently recruiting participants.
Verified February 2013 by Stanford University
Sponsor:
Stanford University
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00767234
First received: October 3, 2008
Last updated: February 25, 2013
Last verified: February 2013
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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:
MedlinePlus related topics:
Anal Cancer
Bladder Cancer
Breast Cancer
Cancer
Colorectal Cancer
Esophageal Cancer
Esophagus Disorders
Pancreatic Cancer
U.S. FDA Resources
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
blood
| 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
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767234
Contacts
| Contact: Shyam Panchal | (650) 725-9810 | spanchal@stanford.edu |
Locations
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Shyam Panchal 650-725-9810 spanchal@stanford.edu | |
| 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
Investigators
| Principal Investigator: | Haruka Itakura | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00767234 History of Changes |
| Other Study ID Numbers: | GI0003, GI0003, 8502 |
| Study First Received: | October 3, 2008 |
| Last Updated: | February 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Gallbladder Neoplasms Adenocarcinoma Adenocarcinoma, Mucinous Anus Neoplasms Urinary Bladder Neoplasms Neoplasms Carcinoma Rectal Neoplasms Colorectal Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Pancreatic Neoplasms Gastrointestinal Stromal Tumors |
Bile Duct Neoplasms Carcinoma, Ductal, Breast Carcinoma, Ductal Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Intestinal Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases Urologic Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013