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NCT Number: NCT02840747

Tissue Repository: CTCL Collection Protocol

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Brigit Lapolla

CONTACT

[email protected]

Larisa J. Geskin, MD

CONTACT

[email protected]

212-305-5293

Larisa J. Geskin, MD

PRINCIPAL_INVESTIGATOR

About this study

CTCL is a heterogeneous group of non-Hodgkin's lymphomas characterized by chronic inflammation and accumulation of malignant T cells in the skin. In order to carry out research to expand the knowledge and develop more effective treatments, tissue samples from CTCL patients with presumed or known disorders are required and tissue samples from control patients will be required to compare the differences between affected and healthy populations.

Scientists will be able to test new ideas and new technologies that are not apparent or available at the present moment from this tissue repository in the future. This type of information will thus be of great advantage to future patients with these diseases.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of biological specimen collections

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Brigit Lapolla

CONTACT

[email protected]

Larisa J. Geskin, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2016
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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