Tissue Repository: CTCL Collection Protocol

NCT ID: NCT02840747

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2026-10-31

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.

Detailed Description

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

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.

No interventions assigned to this group

Healthy Controls

Skin biopsies, blood samples, skin swabs, nasal swabs, cheek epithelium swabs, fecal samples and urine samples may be collected from healthy volunteers.

No interventions assigned to this group

Eligibility Criteria

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.

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larisa J. Geskin, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Larisa J. Geskin, MD

Role: CONTACT

ljg2145@cumc.columbia.edu

Brigit Lapolla

Role: CONTACT

bl2963@cumc.columbia.edu

Facility Contacts

Larisa J. Geskin, MD

Role: primary

ljg2145@cumc.columbia.edu

212-305-5293

Brigit Lapolla

Role: backup

bl2963@cumc.columbia.edu

Other Identifiers

AAAQ8751

Identifier Type: -

Identifier Source: org_study_id