Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by University of Pittsburgh
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: September 12, 2005
Last updated: May 26, 2015
Last verified: May 2015
This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future 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, Urine and Skin Sample Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis 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
Those subjects with cutaneous t-cell lymphoma and Sezary syndrome, atopic dermatitis, or eczema
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, urine, and skin specimens obtained from CTCL, eczema, and atopic dermatitis patients to monitor:

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

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 and atopic dermatitis or eczema patients

Inclusion Criteria:

  • 18 or older
  • able and willing to provide informed consent
  • diagnosed with CTCL
  • diagnosed with either atopic dermatitis or eczema

Exclusion Criteria:

  • Lack of CTCL, atopic dermatitis, or eczema 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 identifier: NCT00177268

Contact: Sue A. McCann, MSN, RN 412-864-3681

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   
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         
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Lisa M Grandinetti, M.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh Identifier: NCT00177268     History of Changes
Other Study ID Numbers: 0411029
Study First Received: September 12, 2005
Last Updated: May 26, 2015
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:
Dermatitis, Atopic
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Sezary Syndrome
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic processed this record on November 27, 2015