Permission to Collect Blood Over Time for Research

Pancreatic Cancer Clinical Trial

Official title:

Predicting DVT Risk in GI Cancer Patients Using Plasma Biomarkers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00767234
• Other study ID #: GI0003
• Secondary ID: GI00038502
• Status: Terminated
• Phase: N/A
• First received: October 3, 2008
• Last updated: July 6, 2016
• Start date: August 2008
• Est. completion date: October 2011

Study information

• Verified date: July 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Anal Cancer
• Anus Neoplasms
• Bile Duct Carcinoma
• Carcinoma
• Carcinoma of the Large Intestine
• Carcinoma, Ductal
• Carcinoma, Hepatocellular
• Colon Rectal Cancer Adenocarcinoma
• Colorectal Neoplasms
• Digestive System Neoplasms
• Esophageal Cancer
• Esophageal Neoplasms
• Gall Bladder Cancer
• Gallbladder Carcinoma
• Gallbladder Neoplasms
• Gastric (Stomach) Cancer
• Gastrointestinal Neoplasms
• Gastrointestinal Stromal Tumor (GIST)
• Gastrointestinal Stromal Tumors
• Gastrooesophageal Cancer
• Hepatobiliary Neoplasm
• Liver Carcinoma
• Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Rectal Neoplasms
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Observation
Standard of Care

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify Biomarkers		3 years	No