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

Completed

• Conditions: Breast Cancer; Head and Neck Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer
• Interventions: Procedure: venipuncture; Radiation: radiation therapy

• Registration Number: NCT00897793
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief 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.

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with epithelial cancers	venipuncture	Patients with head and neck cancer, and lung, breast, colorectal, and prostate cancers who are to undergo radiation therapy
patients with epithelial cancers	radiation therapy	Patients with head and neck cancer, and lung, breast, colorectal, and prostate cancers who are to undergo radiation therapy

Primary Outcome Measures

Name	Time	Method
TGF-beta levels	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.

Trial Locations

Locations (3)

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States