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Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma

NCT ID: NCT00863395

Last Updated: 2014-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to define the mechanisms that underlie the refractory pruritus (itch) in Cutaneous T-Cell Lymphoma (CTCL).

Detailed Description

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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.

Conditions

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Cutaneous T-Cell Lymphoma

Keywords

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pruritis itch CTCL

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Skin Biopsy

Group Type EXPERIMENTAL

skin biopsy

Intervention Type PROCEDURE

Lidocaine 1% c Epinephrine for local anesthesia

Interventions

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skin biopsy

Lidocaine 1% c Epinephrine for local anesthesia

Intervention Type PROCEDURE

Other Intervention Names

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Lidocaine

Eligibility Criteria

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Inclusion Criteria

* Patients with CTCL

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Hordinsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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0705M09523

Identifier Type: -

Identifier Source: org_study_id