Clinical Trial Record

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Permission to Collect Blood Over Time for Research


2008-08


2011-10


2011-10


104

Study Overview

Permission to Collect Blood Over Time for Research

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.

N/A

  • 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
  • GI0003
  • GI0003 (OTHER Identifier) (OTHER: Stanford University)
  • 8502 (OTHER Identifier) (OTHER: Stanford IRB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2008-10-03  

N/A  

2016-07-06  

2008-10-06  

N/A  

2016-07-11  

2008-10-07  

N/A  

2016-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
Identify Biomarkers3 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Haruka Itakura, Stanford University

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available