Tissue Repository: CTCL Collection Protocol



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:July 2016
End Date:August 2019
Contact:Larisa Geskin, MD
Email:ljg2145@cumc.columbia.edu

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

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.

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.

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.
We found this trial at
1
site
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Larisa J Geskin, MD
Phone: 212-305-5293
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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mi
from
New York, NY
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