Permission to Collect Blood Over Time for Research

Sponsor

Stanford University (Other)

Overall Status

Terminated

CT.gov ID

NCT00767234

Collaborator

(none)

104

Enrollment

Location

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

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 :

Aug 1, 2008

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Outcome Measures

Primary Outcome Measures

Identify Biomarkers [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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