Tissue Repository: CTCL Collection Protocol

NCT02840747 | Recruiting

• 1 other identifier: AAAQ8751
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma, T-Cell, Cutaneous; Lymphomatoid Papulosis; Sézary Syndrome

Keywords

Lymphomatoid Papulosis; Sézary Syndrome; T-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of biological specimen collections

  This is a collection protocol to establish a tissue repository for samples from patients with CTCL.

  2 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This protocol is for the collection of biological specimens from patients who fall into the following three groups: 1. Patients with diagnosis of cutaneous T cell lymphoma (diagnosed according to the WHO-EORTC criteria) 2. Patients with benign dermatoses, including but not limited to psoriasis, eczema, and dermatitis. 3. Healthy controls

You may qualify if:

• 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.

You may not qualify if:

• Patients with a history of previous lymphoma other than CTCL or SS or LYP.
• Medical illnesses with potential suppressive or activating impact on immune and bowel function as judged by the investigator.
• Current, viable pregnancy.
• Anemia with a documented hemoglobin laboratory value of \<7.5 g/dl within the past 6 months.
• Previous history of CTCL, SS, LYP, or any lymphoma.
• Previous history of Human Immunodeficiency Virus (HIV) infection.
• Anemia with a documented hemoglobin laboratory value of \<7.5 g/dl within the past 6 months.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Skin biopsies, swabs (skin, cheek epithelium, nasal), samples of blood, fecal and urine.

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Lymphomatoid Papulosis; Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Larisa J. Geskin, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larisa J. Geskin, MD

CONTACT

ljg2145@cumc.columbia.edu

Brigit Lapolla

CONTACT

bl2963@cumc.columbia.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 21, 2016
• Study Start: July 1, 2016
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-11

Locations

US (1)