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

This study is currently recruiting participants.
Verified December 2017 by Oleg E. Akilov, MD, PhD, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT00177268
First Posted: September 15, 2005
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Oleg E. Akilov, MD, PhD, University of Pittsburgh
  Purpose
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 Eczema Atopic Dermatitis Other: Blood draw or skin biopsy

Study Type: Observational
Study Design: Observational Model: Other
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 Oleg E. Akilov, MD, PhD, University of Pittsburgh:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 200
Study Start Date: October 2004
Estimated Study Completion Date: January 2024
Estimated Primary Completion Date: January 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
I
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Criteria

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
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


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: Patrizia Fuschiotti, PhD         
Sub-Investigator: Hassane Zarour, MD         
Principal Investigator: Oleg E. Akilov, MD, Ph.D         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Oleg E Akilov, M.D., PhD University of Pittsburgh
  More Information

Responsible Party: Oleg E. Akilov, MD, PhD, Assistant Professor of Dermatology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177268     History of Changes
Other Study ID Numbers: 0411029
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: December 5, 2017
Last Verified: December 2017
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
eczema
atopic dermatitis

Additional relevant MeSH terms:
Lymphoma
Dermatitis
Lymphoma, T-Cell
Dermatitis, Atopic
Eczema
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Skin Diseases
Lymphoma, Non-Hodgkin
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity