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Blood and Tissue Collection for Cutaneous Lymphoma Research

This study is currently recruiting participants.
Verified January 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177268
First received: September 12, 2005
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

This is a tissue and blood banking protocol for cutaneous t-cell lymphoma (CTCL)patients for current and future CTCL research.


Condition Intervention
Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
 Other: Blood draw or skin biopsy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Peripheral Blood and Skin Sample Collection for Cutaneous Lymphoma Research

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Proteonomics of Cutaneous T-cell lymphoma [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
    Proteonomic variables will be measured in blood and tissue of consented CTCL patients.


Biospecimen Retention:   Samples Without DNA

White blood cells and/or skin biopsy tissue are retained.


Estimated Enrollment: 200
Study Start Date: October 2004
Estimated Study Completion Date: January 2023
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
I
Those subjects with cutaneous t-cell lymphoma and Sezary syndrome
 Other: Blood draw or skin biopsy
Up to 9 blood draws/year of 60 ml of whole blood. One 6 mm punch biopsy may be obtained up to 4 times per year.

Detailed Description:

The purpose of this study is to provide a central mechanism for monitoring access to peripheral blood and skin specimens obtained from CTCL patients to monitor:

  • immunologic assays/flow cytometry
  • tumor progression/regression
  • genomic studies
  • proteomic studies
  • others germane to the advancement of CTCL treatment
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with cutaneous t-cell lymphoma and/or Sezary syndrome

Criteria

Inclusion Criteria:

  • 18 or older
  • able and willing to provide informed consent
  • diagnosed with CTCL

Exclusion Criteria:

  • Lack of CTCL diagnosis in medical record
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177268

Contacts
Contact: Sue A. McCann, MSN, RN 412-864-3681 mccannsa@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sue A. McCann, M.S.N., R.N.     412-624-3782     mccannsa@upmc.edu    
Sub-Investigator: Louis Falo, M.D., Ph.D.            
Sub-Investigator: Geza Erdos, MD, PhD            
Sub-Investigator: Sue A. McCann, MSN, RN            
Sub-Investigator: Pawel Kalinski, MD, PhD            
Sub-Investigator: Patrick Moore, MD            
Sub-Investigator: Yuan Chang, MD            
Sub-Investigator: Oleg Akilov, MD, PhD            
Sub-Investigator: Sara K. Story, MD            
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Larisa J. Geskin, M.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177268     History of Changes
Other Study ID Numbers: 0411029
Study First Received: September 12, 2005
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Blood/tissue banking

Additional relevant MeSH terms:
Lymphoma
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 23, 2013