An Exploratory Evaluation of Biomarkers in Blister Fluid in Healthy Volunteers and Irradiated Skin
Public ClinicalTrials.gov record NCT00923104. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00923104
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 22, 2009
- Primary completion
- Sep 20, 2017
- Completion
- Sep 20, 2017
- Last update posted
- Jul 7, 2025
2009 – 2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00923104, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 7, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00923104 live on ClinicalTrials.gov.