Permission to Collect Blood Over Time for Research

NCT ID: NCT00767234

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Observation

Standard of Care

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haruka Itakura

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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GI0003

Identifier Type: OTHER

Identifier Source: secondary_id

8502

Identifier Type: OTHER

Identifier Source: secondary_id

GI0003

Identifier Type: -

Identifier Source: org_study_id

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