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Blister clinical trials

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NCT ID: NCT00923104 Completed - Breast Cancer Clinical Trials

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

Start date: April 23, 2009
Phase:
Study type: Observational

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.

NCT ID: NCT00086476 Completed - Clinical trials for Blood Coagulation Disorders

Study of Megakaryocytes From Patients With Abnormal Platelet Vesicles

Start date: June 29, 2004
Phase: N/A
Study type: Observational

Congenital bleeding disorders characterized by abnormal platelet granules include Gray Platelet syndrome (GPS; defective alpha-granules), Hermansky-Pudlak syndrome (HPS; defective delta-granules), and combined alpha delta-storage pool deficiency (alpha delta-SPD). Other diseases associated with variable defects in platelet gamma-granules include Chediak-Higashi, Griscelli, Wiskott-Aldrich, and Thrombocytopenia Absent Radius syndromes. These disorders are models for the study of organelle formation in megakaryocytes and platelets. Characteristics of megakaryocytopoiesis in these disorders have not been investigated because megakaryocytes could not be cultured from patients in sufficient quantities for experimental purposes. Recent advances have made it possible to culture megakaryocytes using serum-free media supplemented with recombinant human thrombopoietin (TPO). Such cultured human megakaryocytes, amplified from bone marrow-derived CD34+ stem cells, synthesize and store organellar proteins and produce functional platelets. In this protocol, we plan to obtain bone marrow aspirates from 40 children and adults (ages 2 to 80 years) with GPS, HPS, and related disorders. Patients admitted to the NIH Clinical Center on specific disease-related protocols will be enrolled in this protocol during their routine 3-5 day visits. We will culture megakaryocytes from CD34+ stem cells isolated from bone marrow aspirates. Studies of cultured megakaryocytes will include evaluation of granule membrane and soluble proteins using fluorescent antibodies and immunoelectron microscopy and comparison of RNA and protein expression patterns between normal and patient cells. Precautions will be taken to prevent the primary risk of the bone marrow aspiration, i.e., prolonged bleeding at the aspiration site. Standard diagnostic studies on the bone marrow sample may reveal information that may directly benefit patients. However, the broader benefit of this study is the acquisition of a better understanding of the characteristics of functional platelet disorders and the process of intracellular vesicle formation.

NCT ID: NCT00001150 Completed - Healthy Clinical Trials

Induction of Suction Blisters in Patients With Urticaria, Blistering Diseases, Inflammatory Dermatoses and Neoplastic Disorders, and in Normal Volunteers

Start date: October 1976
Phase: N/A
Study type: Observational

The use of a suction blister apparatus has facilitated study of the immunologic capacity of human epidermal cells. We have been able to prepare purified populations of these cells after blister formation. Specifically, using the blister tops, we are able to enrich for epidermal Langerhans cells which are very potent stimulators in antigen presenting assays. Thus, this normal volunteer study provides an important source of fresh epidermal tissue from which we can study normal epidermal Langerhans cell function. In addition, we have recently used blister roofs in important experimental models of HIV-1 transmission. There is no other method available for assessing the biologic function of freshly isolated Langerhans cells without altering their milieu. It is a very safe and effective way to obtain human epidermal samples.