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Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma (CTCL)

Primary Purpose

Cutaneous T-Cell Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
skin biopsy
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cutaneous T-Cell Lymphoma focused on measuring pruritis, itch, CTCL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with CTCL

Exclusion Criteria:

  • None

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Skin Biopsy

Arm Description

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2009
Last Updated
March 28, 2014
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00863395
Brief Title
Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma
Acronym
CTCL
Official Title
Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-Cell Lymphoma
Keywords
pruritis, itch, CTCL

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skin Biopsy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
skin biopsy
Other Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine 1% c Epinephrine for local anesthesia
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with CTCL Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma

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