Full Text View
Tabular View
No Study Results Posted
Related Studies
Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma (CTCL)
This study is currently recruiting participants.
Verified by University of Minnesota, August 2009
First Received: February 24, 2009   Last Updated: August 12, 2009   History of Changes
Sponsored by: University of Minnesota
Information provided by: University of Minnesota
ClinicalTrials.gov Identifier: NCT00863395
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by University of Minnesota:

Primary Outcome Measures:
  • Collection of biopsies from pruritic CTCL patients, non pruritic CTCL patients and controls and analysis of a panel of itch-associated local biomarkers in an attempt to characterize and quantify the components in the skin involved. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with CTCL

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863395

Contacts
Contact: Patrice Webster 612-626-5941 webst019@umn.edu
Contact: Cynthia Mc Gill 612-626-5827 mcgil018@umn.edu

Locations
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            
Sponsors and Collaborators
University of Minnesota
Investigators
Principal Investigator: Maria Hordinsky, MD University of Minnesota
  More Information

No publications provided

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

Keywords provided by University of Minnesota:
pruritis
itch
CTCL

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 11, 2009