NIH Clinical Research Studies

Protocol Number: 09-C-0120

Active Accrual, Protocols Recruiting New Patients

Title:
An Exploratory Evaluation of Biomarkers in Blister Fluid in Healthy Volunteers and Irradiated Skin
Number:
09-C-0120
Summary:
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).

Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

2.1.1.1 Histological diagnosis: Pathologically confirmed diagnosis of 1) invasive breast cancer, 2) ductal carcinoma in situ, or 3) adenocarcinoma of the prostate.

2.1.1.2 Patients in whom the management of the histologic diagnosis will include radiation treatment as part of standard clinical management.

2.1.1.3 Patients in whom the extent of disease is considered local or locoregional (ie. requiring definitive radiotherapy to the breast or prostate).

2.1.1.4 Patients must be older than 18 years of age.

2.1.1.5 Patients must have a primary medical or surgical oncologist in the community or at NCI who is wiling to collaborate with the ROB staff in the clinical management of the patient.

2.1.1.6 Patients of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated with radiotherapy on this study.

2.1.1.7 Patients must have an ECOG performance status of 0-2 and a life expectancy greater than 12 months.

EXCLUSION CRITERIA:

2.1.2.1 Patients with a history of chronic skin disease such as psoriasis, eczema, or history of keloid formation.

2.1.2.2 Patients requiring concurrent use of topical steriods

2.1.2.3 Patients requiring concurrent use of glucocorticoid therapy.

2.1.2.4 Patients who have received topical or systemic chemotherapy within 4 weeks of enrollment (not including hormonal agents such as antiandrogens, GnRH agonists, aromatase inhibitors, tamoxifen, and similar agents) are excluded.

2.1.2.5 Patients requiring concurrent chemotherapy with radiotherapy except as noted in 2.1.2.3 are excluded.

2.1.2.6 Patients with a history of lupus erythematosis, scleroderma, ataxia telengiectasia or other known hypersensitivity to therapeutic radiation.

2.1.2.7 Patients with prior radiotherapy to the site which would be used for blister induction.

2.1.2.8 Patients who are pregnant because of the potential mutagenic effects of radiation on a developing fetus or newborn.

2.1.2.9 Patients with unrelated systemic illness which in the judgment of the Principal Investigator (PI) would compromise the patient's ability to tolerate this therapy or are likely to interfere with the study procedures or results.

2.1.2.10 Patients who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment.

2.1.2.11Patients with significant skin atrophy that would interfere with blister formation.

2.1.2.12Breast cancer patients in whom the site of radiotherapy includes a myocutaneous flap or skin graft.

ELIGIBILITY CRITEREIA FOR HEALTHY VOLUNTEERS:

INCLUSION CRITERIA:

2.2,1.1 Healthy volunteers older than 18 years of age.

2.2.1.2 Ability to provide informed consent.

EXCLUSION CRITERIA:

2.2.2.1 History of chronic skin disease such as psoriasis, eczema, or history of keloid formation.

2.2.2.2 Concurrent use of glucocorticoid therapy.

2.2.2.3 History of lupus erythematosis, scleroderma, ataxia telengiectasia or other known hypersensitivity to therapeutic radiation.

2.2.2.4 Prior radiotherapy to the site which would be used for blister induction (for benign or malignant causes).

2.2.2.5 Unrelated systemic illness which in the judgment of the Principal Investigator (PI) would compromise the patient's ability to tolerate blister induction or are likely to interfere with blister healing, the study procedures, or the study results.

2.2.2.6 Darkly pigmented skin in whom pigmentation changes are a likely complication

2.2.2 7 Significant skin atrophy that would interfere with blister formation.

Special Instructions:
Currently Not Provided
Keywords:
Radiation
Blister
Healthy Volunteer
Samples
Recruitment Keyword(s):
None
Condition(s):
Prostate Cancer
Breast Cancer
Healthy Volunteer
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Cancer Institute

Contact(s):
NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):
Thames HD, Bentzen SM, Turesson I, Overgaard M, Van den Bogaert W. Time-dose factors in radiotherapy: a review of the human data. Radiother Oncol. 1990 Nov;19(3):219-35.

Hopewell JW. Mechanisms of the action of radiation on skin and underlying tissues. Br J Radiol Suppl. 1986;19:39-47.

Emami B, Lyman J, Brown A, Coia L, Goitein M, Munzenrider JE, Shank B, Solin LJ, Wesson M. Tolerance of normal tissue to therapeutic irradiation. Int J Radiat Oncol Biol Phys. 1991 May 15;21(1):109-22.

Active Accrual, Protocols Recruiting New Patients

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