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Blood and Tissue Collection for Cutaneous Lymphoma Research

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 16, 2013
Last verified: December 2013
  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:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Proteomics of Cutaneous T-cell lymphoma [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
    Proteomic 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: Einat Rabinovich, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Lisa M Grandinetti, 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: December 16, 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
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Mycoses
Mycosis Fungoides
Sezary Syndrome
Syndrome
Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014