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NCT00923104 · ClinicalTrials.gov registry record
An Exploratory Evaluation of Biomarkers in Blister Fluid in Healthy Volunteers and Irradiated Skin
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 61
- Enrollment target
NCT00923104: Completed study, sponsored by National Cancer Institute (NCI).
NCT00923104 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 61 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923104 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 61 participants
- Enrollment target
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
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2009-04-23 |
| Est. Completion | 2017-09-21 |
What the finished NCT00923104 record still lists
NCT00923104 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 61 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00923104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00923104 about?
NCT00923104 is a clinical study titled "An Exploratory Evaluation of Biomarkers in Blister Fluid in Healthy Volunteers and Irradiated Skin". 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 t...
What is the current status of trial NCT00923104?
This trial is currently completed. The enrollment target is 61 participants. The study started on 2009-04-23. Estimated completion is 2017-09-21.
Who is sponsoring clinical trial NCT00923104?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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