Tissue Repository: CTCL Collection Protocol

  • days left to enroll
  • participants needed
  • sponsor
    Columbia University
Updated on 14 May 2022
skin disorder
sezary syndrome
sezary cell count
Accepts 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.

Condition Lymphoma, T-Cell, Cutaneous, Lymphomatoid Papulosis, Sézary Syndrome
Clinical Study IdentifierNCT02840747
SponsorColumbia University
Last Modified on14 May 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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