Permission to Collect Blood Over Time for Research

NCT00767234 | Terminated DMC

• 2 other identifiers: GI00038502
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Identify Biomarkers

  3 years

Interventions

Observation PROCEDURE

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Active cancers of the GI tract

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Pancreatic Neoplasms; Gastrointestinal Neoplasms; Esophageal Neoplasms; Gallbladder Neoplasms; Stomach Neoplasms; Gastrointestinal Stromal Tumors; Carcinoma, Hepatocellular; Bile Duct Neoplasms; Colonic Neoplasms; Anus Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases; Stomach Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Liver Neoplasms; Liver Diseases; Bile Duct Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Neoplasms; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Haruka Itakura

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 7, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

US (1)