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

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT00177268
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 327
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	Phase
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

Study Design

• Study Type: Observational
• Anticipated 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: Oct 1, 2004
• Anticipated Primary Completion Date: Jan 1, 2030
• Anticipated Study Completion Date: Jan 1, 2032

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Proteomics of Cutaneous T-cell lymphoma [Ongoing]

   Proteomic variables will be measured in blood and tissue of consented CTCL patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh

Investigators

• Principal Investigator: Oleg E Akilov, M.D., PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Sep 15, 2005
• Last Update Posted: Nov 17, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Oleg E. Akilov, MD, PhD, Assistant Professor of Dermatology, University of Pittsburgh: Cutaneous T-cell Lymphoma; Sezary Syndrome; Mycosis Fungoides; Blood/tissue banking; eczema; atopic dermatitis
• Additional relevant MeSH terms: Mycoses; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous; Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Nov 17, 2021