Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer

April 10, 2013 updated by: A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

A Pilot Study of TGF-beta as a Potential Target for Prevention of Radiation-Induced Injury

RATIONALE: Measuring levels of transforming growth factor-beta (TGF-beta) in the blood of patients with epithelial cancers (head and neck, lung, breast, colorectal, and prostate) may help doctors predict how patients will respond to treatment with radiation therapy.

PURPOSE: This research study is measuring levels of TGF-beta in patients with epithelial cancers who are undergoing radiation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To determine whether there is a dose-dependent increase in TGF-beta following radiotherapy in patients with epithelial cancers.

OUTLINE: Patients undergo blood sample collection prior to treatment, 24-72 hours after the first fraction of radiotherapy, and at the end of radiotherapy. Patients will also be asked for a weekly blood sample, but this is optional. Samples are analyzed to compare pre- and post-treatment TGF-beta levels.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

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

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center at Franklin

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People who have epithelial cancers and who will undergo radiation therapy

Description

DISEASE CHARACTERISTICS:

  • Known diagnosis of an epithelial cancer, including any of the following:

    • Head and neck
    • Lung
    • Breast
    • Colorectal
    • Prostate
  • Radiotherapy must be a component of planned treatment therapy

PATIENT CHARACTERISTICS:

  • No serious medical or psychiatric illnesses which would prevent informed consent

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with epithelial cancers
Patients with head and neck cancer, and lung, breast, colorectal, and prostate cancers who are to undergo radiation therapy
Procedure: venipuncture
Venipuncture for blood samples. Samples will be tested for TGF-beta.
Other Names:
  • blood sample collection
Radiation: radiation therapy
Radiation treatments vary according to type of cancer and by patient per doctors' recommendation
Other Names:
  • x-ray treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TGF-beta levels
Time Frame: day 1 prior to treatment, 24-72 hours after 1st treatment, weekly at treatment (optional) and at completion of treatment
TGF-beta is a protein that can be detected in the blood.
day 1 prior to treatment, 24-72 hours after 1st treatment, weekly at treatment (optional) and at completion of treatment

Collaborators and Investigators

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

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: A. Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

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 Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

April 12, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC RAD 0576
  • P30CA068485 (U.S. NIH Grant/Contract)
  • VU-VICC-RAD-0576

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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