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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00897793
First received: May 9, 2009
Last updated: April 10, 2013
Last verified: April 2013

May 9, 2009
April 10, 2013
January 2006
July 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
TGF-beta is a protein that can be detected in the blood.
TGF-beta levels [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897793 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

venous blood

Probability Sample

People who have epithelial cancers and who will undergo radiation therapy

  • Breast Cancer
  • Colorectal Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Prostate Cancer
  • Procedure: venipuncture
    Venipuncture for blood samples. Samples will be tested for TGF-beta.
    Other Name: blood sample collection
  • Radiation: radiation therapy
    Radiation treatments vary according to type of cancer and by patient per doctors' recommendation
    Other Name: x-ray treatment
patients with epithelial cancers
Patients with head and neck cancer, and lung, breast, colorectal, and prostate cancers who are to undergo radiation therapy
Interventions:
  • Procedure: venipuncture
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00897793
VICC RAD 0576, P30CA068485, VU-VICC-RAD-0576
No
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP