CTCL: Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma

Sponsor

University of Minnesota (Other)

Overall Status

Terminated

CT.gov ID

NCT00863395

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Cutaneous T-Cell Lymphoma	Procedure: skin biopsy	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Skin Biopsy	Procedure: skin biopsy Lidocaine 1% c Epinephrine for local anesthesia Other Names: Lidocaine

Arm

Intervention/Treatment

Experimental: Skin Biopsy

Procedure: skin biopsy

Lidocaine 1% c Epinephrine for local anesthesia

Other Names:

Lidocaine

Outcome Measures

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. [3 years]