A Tissue Repository for the Collection of Samples From Patients With Cutaneous T Cell Lymphoma and Healthy Volunteers

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This document is a protocol for a non-interventional human research study in which the investigator hopes to better understand the changes that take place in T cells in Cutaneous T-cell lymphoma (CTCL). The purpose of this study is to establish a protocol for the collection and storage of tissue samples from patients with CTCL for future research studies. Collection and storage of tissue samples from control patients will also be carried out.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Patients with CTCL or Lymphomatoid Papulosis (LYP): a clinical or histologic diagnosis of a) newly diagnosed, b) progressive, or c) relapsed CTCL or LYP who are initiating or changing therapy.

• Patients with Sézary Syndrome (SS) or stage IV B CTCL as defined by blood involvement on flow cytometry or morphology: (1) ≥1000/μL Sézary cells by morphology; (2) Cluster of differentiation 4 (CD4)/cluster of differentiation 8 (CD8) ratio ≥10; (3) CD4+cluster of differentiation 7 (CD7)- cells ≥40 percent; (4) or CD4+cluster of differentiation 26 (CD26)- cells ≥30 percent.

• Ability to understand and willing to sign a willing informed consent document.

• Age ≥ 18 years.

• Matched for sex, and age +/- 10 years.

• Ability to sign informed consent document.

• Patients with or without benign inflammatory skin conditions including, but not limited to, eczema, psoriasis, or dermatitis or Patients without skin conditions requiring treatment with systemic immunosuppressive, biologic, or chemotherapeutic agents.

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Larisa J. Geskin, MD
ljg2145@cumc.columbia.edu
Backup
Brigit Lapolla
bl2963@cumc.columbia.edu
Time Frame
Start Date: 2016-07
Estimated Completion Date: 2025-10
Participants
Target number of participants: 400
Treatments
Patients with CTCL
Skin biopsies, blood samples, skin swabs, nasal swabs, cheek epithelium swabs, fecal samples and urine samples may be collected from patients with CTCL (according to World Health Organization-European Organization for Research and Treatment of Cancer (WHO-EORTC) criteria).
Patients with benign dermatoses
Skin biopsies, blood samples, skin swabs, nasal swabs, cheek epithelium swabs, fecal samples and urine samples may be collected from patients with benign dermatoses, including but not limited to conditions such as eczema, psoriasis, and dermatitis.
Healthy Controls
Skin biopsies, blood samples, skin swabs, nasal swabs, cheek epithelium swabs, fecal samples and urine samples may be collected from healthy volunteers.
Authors
Sponsors
Leads: Columbia University

This content was sourced from clinicaltrials.gov