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Sponsored by: |
University of Minnesota |
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Information provided by: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00863395 |
The purpose of this study is to define the mechanisms that underlie the refractory pruritus (itch) in Cutaneous T-Cell Lymphoma (CTCL).
Condition | Intervention | Phase |
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Cutaneous T-Cell Lymphoma |
Procedure: skin biopsy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma |
Estimated Enrollment: | 20 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Procedure: skin biopsy
Lidocaine 1% c Epinephrine for local anesthesia
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Little is known about the fundamental cause of pruritus in CTCL, however we do know the malignant CD4+ T-cells of CTCL accumulate in the epidermis and are in close proximity to the neural, immune and vascular systems that influence and regulate the biology of the skin. The close proximity of malignant CD4+ T-cells with the key mediators in the itch process could result in the pruritus experienced by patients with CTCL. To accomplish this we are collecting and examining skin biopsies for CTCL patients and healthy controls to identify itch-associated local biomarkers of the disease. In addition to these skin biopsies, we are retrospectively examining existing paraffin-embedded skin biopsy tissue blocks from CTCL patients. We are performing comparative and quantitative immunohistochemical analyses on the samples. This study will help to determine which components in the skin are potential key players in the manifestation and maintenance of recalcitrant pruritus in patients with CTCL.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patrice Webster | 612-626-5941 | webst019@umn.edu |
Contact: Cynthia Mc Gill | 612-626-5827 | mcgil018@umn.edu |
United States, Minnesota | |
University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Maria Hordinsky, MD 612-625-8625 hordi001@umn.edu | |
Principal Investigator: Maria Hordinsky, MD |
Principal Investigator: | Maria Hordinsky, MD | University of Minnesota |
Responsible Party: | Unniversity of Minnesota ( Maria Hordinsky, MD ) |
Study ID Numbers: | 0705M09523 |
Study First Received: | February 24, 2009 |
Last Updated: | August 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00863395 History of Changes |
Health Authority: | United States: Institutional Review Board |
pruritis itch CTCL |
Pruritus Immunoproliferative Disorders Lidocaine Anesthetics Sezary Syndrome Mycosis Fungoides Mycoses Lymphatic Diseases |
Cutaneous T-cell Lymphoma Lymphoma, T-Cell Epinephrine Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Lymphoma, T-Cell, Cutaneous |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Lymphoma, T-Cell |
Sezary Syndrome Mycosis Fungoides Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |