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

February 16, 2024 updated by: Oleg E. Akilov, MD, PhD, University of Pittsburgh

Peripheral Blood, Urine and Skin Sample Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Charity L Ruhl, LPN
  • Phone Number: 4126472013
  • Email: ruhlcl@upmc.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Sub-Investigator:
          • Louis Falo, M.D., Ph.D.
        • Sub-Investigator:
          • Patrizia Fuschiotti, PhD
        • Sub-Investigator:
          • Hassane Zarour, MD
        • Principal Investigator:
          • Oleg E. Akilov, MD, Ph.D
        • Sub-Investigator:
          • Nicolena Verardi, PA-C
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteomics of Cutaneous T-cell lymphoma
Time Frame: Ongoing
Proteomic variables will be measured in blood and tissue of consented CTCL patients.
Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2032

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimated)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19010322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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