Tissue Repository: CTCL Collection Protocol

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02840747

Enrollment

400

Registered

2016-07-21

Start date

2016-07-31

Completion date

2026-10-31

Last updated

2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Lymphomatoid Papulosis, Sézary Syndrome, T-Cell Lymphoma

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactLarisa J. Geskin, MD

ljg2145@cumc.columbia.edu

Backup ContactBrigit Lapolla

bl2963@cumc.columbia.edu

Outcome results