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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00923104
First received: June 17, 2009
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.

Condition
Breast Cancer
Healthy Volunteer
Prostate Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Exploratory Evaluation of Biomarkers in Blister Fluid in Healthy Volunteers and Irradiated Skin

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To determine if cytokine levels in blister fluid change following exposure of the skin to low or high dose radiation. [ Time Frame: At the completion of the study ] [ Designated as safety issue: No ]
  • To compare blister fluid cytokine levels in blister fluid from unirradiated skin in normal controls, breast cancer patients, and prostate cancer patients [ Time Frame: At the completion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if there are differences within circulating and skin proteome and cytokine patterns between participants with cancer and healthy normal controls [ Time Frame: At the completion of the study ] [ Designated as safety issue: No ]
  • To determine how proteomic pattern changes in skin correlate with circulating proteomic patterns. [ Time Frame: At the completion of the study ] [ Designated as safety issue: No ]
  • To determine if changes in the proteome in blister fluid occur following exposure of the skin to low or high dose radiation. [ Time Frame: At the completion of the study ] [ Designated as safety issue: No ]
  • To evaluate the reproducibility of cytokine assays in simultaneously collected blister fluid samples from normal patients. [ Time Frame: At the completion of the study ] [ Designated as safety issue: No ]
  • To determine how cytokine levels in skin correlate with circulating and urinary cytokine levels. [ Time Frame: At the completion of the study ] [ Designated as safety issue: No ]
  • 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 (& gt; Grade 3), or late RTOG skin toxicity (& gt; Grade 2). [ Time Frame: At the completion of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: April 2009
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 steroids

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923104

Contacts
Contact: Sharon L Smith, R.N. (301) 451-8905 smiths@mail.nih.gov
Contact: Deborah E Citrin, M.D. (301) 496-5457 citrind@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Deborah E Citrin, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00923104     History of Changes
Other Study ID Numbers: 090120, 09-C-0120
Study First Received: June 17, 2009
Last Updated: May 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Radiation
Blister
Healthy Volunteer
Samples
Prostate Cancer
Breast Cancer
HV

Additional relevant MeSH terms:
Blister
Breast Neoplasms
Prostatic Neoplasms
Breast Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Pathological Conditions, Anatomical
Prostatic Diseases
Skin Diseases
Skin Diseases, Vesiculobullous
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014