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
  Purpose

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.


Condition Intervention
Breast Cancer
Colorectal Cancer
Head and Neck Cancer
Lung Cancer
Prostate Cancer
Procedure: venipuncture
Radiation: radiation therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of TGF-beta as a Potential Target for Prevention of Radiation-Induced Injury

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

venous blood


Enrollment: 25
Study Start Date: January 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

People who have epithelial cancers and who will undergo radiation therapy

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897793

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: A Bapsi Chakravarthy, MD, Associate Professor, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00897793     History of Changes
Other Study ID Numbers: VICC RAD 0576, P30CA068485, VU-VICC-RAD-0576
Study First Received: May 9, 2009
Last Updated: April 10, 2013
Health Authority: United States: Vanderbilt University Human Research Protection Program

Keywords provided by Vanderbilt-Ingram Cancer Center:
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage I squamous cell carcinoma of the larynx
stage I verrucous carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent adenoid cystic carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent verrucous carcinoma of the oral cavity
stage I adenoid cystic carcinoma of the oral cavity
stage I mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity

Additional relevant MeSH terms:
Lung Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Breast Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 16, 2014