An Exploratory Evaluation of Biomarkers in Blister Fluid in Healthy Volunteers and Irradiated Skin
BACKGROUND:
Blister fluid has been used to measure cytokine expression, proteomic profiles, and
pharmacokinetics in a variety of disease states.
Blister fluid inside radiation treatment fields has been shown to have altered expression of
cytokines and products of collagen metabolism.
Evaluation of blister fluid in normal skin inside and outside the radiation field may allow
the development of a minimally invasive marker of radiation exposure or damage induced by
radiation in irradiated skin.
OBJECTIVES:
This protocol will evaluate the ability to determine a cytokine pattern and global changes
at the protein level measured in blister fluid that correlates with radiation exposure,
absorbed skin dose, or skin toxicity from patients receiving radiation.
ELIGIBILITY:
Patients in whom radiotherapy is required for standard management of their breast or
prostate cancer.
Healthy volunteers with no history of cutaneous inflammatory condition of the skin such as
eczema, or psoriasis.
DESIGN:
This protocol is designed to evaluate blister fluid in and out of the radiation field in
patients that are receiving radiation therapy and in healthy volunteers.
Patients will undergo blister induction and blister fluid collection prior to treatment
outside of the radiation field, and after completion of radiation within the radiation
field.
Blisters will be induced in a non-sun exposed area and if possible in matched sites (i.e.
left and right).
Observational
Time Perspective: Prospective
Deborah E Citrin, M.D.
Principal Investigator
National Cancer Institute (NCI)
United States: Federal Government
090120
NCT00923104
April 2009
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |