Tissue Repository: CTCL Collection Protocol

Columbia University

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT02840747

AAAQ8751

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

400 participants in 3 patient groups

Patients with CTCL

Description:

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

Description:

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

Description:

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