An Exploratory Evaluation of Biomarkers in Blister Fluid in Healthy Volunteers and Irradiated Skin
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|ClinicalTrials.gov Identifier: NCT00923104|
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : December 28, 2018
- Blister fluid contains many of the same biomarkers (substances that can be used to determine the effects of certain kinds of treatments) as blood and urine samples, particularly regarding changes in the skin.
- The Radiation Oncology Branch and others are conducting research studies that require blood and urine samples from healthy volunteers and from patients with cancer. In addition to these samples, researchers would like to collect the fluid from blisters to examine markers of inflammation in the skin.
- To compare blood, urine, and blister fluid samples of patients with cancer who are undergoing radiation therapy to that of volunteers without cancer who will not be receiving radiation therapy.
- To gather more information about the effects of radiation therapy on the skin and body fluids of individuals.
- Patients 18 years of age and older who will be receiving radiation therapy for either breast or prostate cancer.
- A separate group of healthy volunteers will also participate in this study.
- Physical examination and blood samples to determine eligibility for the study.
- Blister induction, conducted before the start of radiation treatment, at completion of radiotherapy (last day of treatment), and at a visit 12 months after the end of radiation treatment.
- Blisters will be created through the use of a suction blister device on the hip (for patients with prostate cancer) or on the treated breast or location of removed breast (for patients with breast cancer).
- Blisters will take approximately 30 minutes to form, and fluid will be removed with a needle and syringe.
- Blood and urine samples will also be collected at this time.
- Radiation treatment for breast or prostate cancer will be conducted according to standard procedures, or as directed by a separate research protocol.
- Evaluations during the treatment period:
- Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant.
- Blood and urine tests.
- Disease evaluation.
- Post-treatment evaluations:
- Clinic visits at months 1, 3, 6, 9, and 12 after the end of radiation therapy for physical examination and disease assessment.
- Study will end 1 year after the final radiation treatment, upon the collection of the final (third) blister fluid sample.
|Condition or disease|
|Breast Cancer Healthy Volunteer Prostate Cancer|
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.
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.
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.
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).
|Study Type :||Observational|
|Actual Enrollment :||61 participants|
|Official Title:||An Exploratory Evaluation of Biomarkers in Blister Fluid in Healthy Volunteers and Irradiated Skin|
|Study Start Date :||April 9, 2009|
subjects with breast cancer, ductal carcinoma in situ, and adenocarcinoma of prostate
- To determine if cytokine levels in blister fluid change following exposure of the skin to low or high dose radiation. [ Time Frame: Study completion ]The primary objectives of this study are (i) to determine if cytokine levels in blister fluid change following exposure of skin to low or high dose radiation, and (ii) to compare cytokine levels in blister fluid from unirradiated skin in normal controls, breast cancer patients, and prostate cancer patients. We will examine IL- 1 beta, IL6, TNF-alpha, and MMP-1 and -3 for the primary analysis. The remaining cytokines will be examined in secondary analyses.
- To compare blister fluid cytokine levels in blister fluid from unirradiated skin in normal controls, breast cancer patients, and prostate cancer patients [ Time Frame: Study completion ]The primary objectives of this study are (i) to determine if cytokine levels in blister fluid change following exposure of skin to low or high dose radiation, and (ii) to compare cytokine levels in blister fluid from unirradiated skin in normal controls, breast cancer patients, and prostate cancer patients. We will examine IL- 1 beta, IL6, TNF-alpha, and MMP-1 and -3 for the primary analysis. The remaining cytokines will be examined in secondary analyses.
- To determine if changes in the proteome in blister fluid occur following exposure of the skin to low or high dose radiation [ Time Frame: Study completion ]
- To determine if cytokine levels and changes at the proteome level measured in blister fluid correlate with absorbed radiation skin dose, acute RTOG skin toxicity (>Grade 3), or late RTOG skin toxicity (>Grade 2). [ Time Frame: Study completion ]
- To determine how cytokine levels in skin correlate with circulating and urinary cytokine levels. [ Time Frame: Study completion ]
- To determine how proteomic pattern changes in skin correlate with circulating proteomic patterns. [ Time Frame: Study completion ]
- To determine if there are differences within circulating and skin proteome and cytokine patterns between participants with cancer and healthy normal controls [ Time Frame: Study completion ]
- To evaluate the reproducibility of cytokine assays in simultaneously collected blister fluid samples from normal patients. [ Time Frame: Study completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923104
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Deborah E Citrin, M.D.||National Cancer Institute (NCI)|