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An Exploratory Evaluation of Biomarkers in Blister Fluid in Healthy Volunteers and Irradiated Skin

NCT00923104 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2025-07-08

No results posted yet for this study

Summary

Background:

* 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.

Objectives:

* 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.

Eligibility:

* 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.

Design:

* 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.

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Deborah E Citrin, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-23
Primary Completion
2017-09-21
Completion
2017-09-21

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00923104 on ClinicalTrials.gov