Viewing Study NCT00863395


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Study NCT ID: NCT00863395
Status: TERMINATED
Last Update Posted: 2014-03-31
First Post: 2009-02-24
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma
Sponsor: University of Minnesota
Organization:

Study Overview

Official Title: Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma
Status: TERMINATED
Status Verified Date: 2014-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CTCL
Brief Summary: The purpose of this study is to define the mechanisms that underlie the refractory pruritus (itch) in Cutaneous T-Cell Lymphoma (CTCL).
Detailed Description: 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: