Tissue Repository: CTCL Collection Protocol

Lymphoma, T-Cell, Cutaneous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02840747
• Other study ID #: AAAQ8751
• Status: Recruiting
• Start date: July 2016
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: Larisa J. Geskin, MD
• Email: ljg2145[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Se´zary Syndrome (SS) or stage IV B CTCL as defined by blood involvement on flow cytometry or morphology: (1) =1000/µL Se´zary 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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphomatoid Papulosis
• Se´zary Syndrome
• Sezary Syndrome

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of biological specimen collections	This is a collection protocol to establish a tissue repository for samples from patients with CTCL.	2 years