Clinical trial NCT02840747: Tissue Repository: CTCL Collection Protocol
Official title: A Tissue Repository for the Collection of Samples From Patients With Cutaneous T Cell Lymphoma and Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma, T-Cell, Cutaneous
Lymphomatoid Papulosis
Sézary Syndrome
Keywords: Lymphomatoid Papulosis
Sézary Syndrome
T-Cell Lymphoma
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This protocol is for the collection of biological specimens from patients who fall into the following three groups:

1. Patients with diagnosis of cutaneous T cell lymphoma (diagnosed according to the WHO-EORTC criteria)
2. Patients with benign dermatoses, including but not limited to psoriasis, eczema, and dermatitis.
3. Healthy controls

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.

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.

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.

Primary outcomes:
measure: Number of biological specimen collections
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Larisa J. Geskin, MD
role: PRINCIPAL_INVESTIGATOR
References: