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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897793
• Other study ID #: VICC RAD 0576
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: April 10, 2013
• Start date: January 2006
• Est. completion date: July 2010

Study information

• Verified date: April 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Vanderbilt University Human Research Protection Program
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• venipuncture
Venipuncture for blood samples. Samples will be tested for TGF-beta.

Radiation:
• radiation therapy
Radiation treatments vary according to type of cancer and by patient per doctors' recommendation

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TGF-beta levels	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	No