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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Colonic Diseases Colonic Neoplasms Colorectal Cancer Colorectal Neoplasms Cranial Nerve Diseases Digestive System Diseases Digestive System Neoplasms Esthesioneuroblastoma, Olfactory Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Olfactory Nerve Diseases Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venipuncture

Procedure

Venipuncture for blood samples. Samples will be tested for TGF-beta.

Other names: blood sample collection

radiation therapy

Radiation

Radiation treatments vary according to type of cancer and by patient per doctors' recommendation

Other names: x-ray treatment

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2010
First posted: May 12, 2009
Registry last updated: Apr 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed