Permission to Collect Blood Over Time for Research

Stanford University

Status: Terminated

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

Treatments: Procedure: Observation

Study type: Observational

Funder types: Other

Identifiers

NCT00767234

8502 (Other Identifier)

GI0003 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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