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Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Cutaneous T-Cell Lymphoma

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Trial Information

Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma


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.


Inclusion Criteria:



- Patients with CTCL

Exclusion Criteria:

- None

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Maria Hordinsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute

Authority:

United States: Institutional Review Board

Study ID:

0705M09523

NCT ID:

NCT00863395

Start Date:

December 2008

Completion Date:

December 2012

Related Keywords:

  • Cutaneous T-cell Lymphoma
  • pruritis
  • itch
  • CTCL
  • Lymphoma
  • Pruritus
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

University of Minnesota Minneapolis, Minnesota  55455