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

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ClinicalTrials.gov Identifier: NCT00177268
Recruitment Status : Recruiting
First Posted : September 15, 2005
Last Update Posted : November 17, 2022
Information provided by (Responsible Party):
Oleg E. Akilov, MD, PhD, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment
Cutaneous T-cell Lymphoma Sezary Syndrome Mycosis Fungoides Eczema Atopic Dermatitis Other: Blood draw, skin biopsy or urine collection

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Peripheral Blood, Urine and Skin Sample Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Study Start Date : October 2004
Estimated Primary Completion Date : January 2030
Estimated Study Completion Date : January 2032

Group/Cohort Intervention/treatment
CTCL, atopic dermatitis, eczema
Those subjects with cutaneous t-cell lymphoma and Sezary syndrome, atopic dermatitis, or eczema may participate as appropriate with the potential for blood, tissue or urine sampling.
Other: Blood draw, skin biopsy or urine collection
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.

Primary Outcome Measures :
  1. Proteomics of Cutaneous T-cell lymphoma [ Time Frame: Ongoing ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177268

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

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United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sue A. McCann, M.S.N., R.N.    412-864-3681    mccannsa@upmc.edu   
Contact: Oleg Akilov, MD, PhD    412-647-4200    akilovoe@upmc.edu   
Sub-Investigator: Louis Falo, M.D., Ph.D.         
Sub-Investigator: Sue A. McCann, MSN, RN         
Sub-Investigator: Patrizia Fuschiotti, PhD         
Sub-Investigator: Hassane Zarour, MD         
Principal Investigator: Oleg E. Akilov, MD, Ph.D         
Sub-Investigator: Nicolena Verardi, PA-C         
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Oleg E Akilov, M.D., PhD University of Pittsburgh
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Responsible Party: Oleg E. Akilov, MD, PhD, Assistant Professor of Dermatology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177268    
Other Study ID Numbers: 0411029
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Oleg E. Akilov, MD, PhD, University of Pittsburgh:
Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Blood/tissue banking
atopic dermatitis
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Dermatitis, Atopic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Lymphoma, Non-Hodgkin
Bacterial Infections and Mycoses