Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT02840747

Conditions

Lymphoma, T-Cell, Cutaneous

Lymphomatoid Papulosis

Sézary Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT02840747

Start date

Jul, 2016

Status verified date

Nov, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Inclusion Criteria for Age and Sex Matched Controls:

  • 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.

Exclusion Criteria:

  • 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.

Exclusion Criteria for Age and Sex Matched Controls:

  • 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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Number of biological specimen collections [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Larisa J. Geskin, MD

ljg2145@cumc.columbia.edu

Brigit Lapolla

bl2963@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Larisa J. Geskin, MD

212-305-5293ljg2145@cumc.columbia.edu

Brigit Lapolla

bl2963@cumc.columbia.edu

Principal Investigator:

Larisa J. Geskin, MD

More Information

Sponsor

Columbia University

Last update posted

Nov 4, 2025

Last verified

Nov, 2025

Keywords

  • Lymphomatoid Papulosis
  • Sézary Syndrome
  • T-Cell Lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Columbia University on 2025-11-04.