Tissue Repository: CTCL Collection Protocol

  • STATUS
    Recruiting
  • End date
    Jan 20, 2023
  • participants needed
    400
  • sponsor
    Columbia University
Updated on 20 March 2021
lymphoma
skin disorder
psoriasis
eczema
sezary syndrome
sezary cell count

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.

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.

Details
Condition Lymphomatoid Papulosis, cutaneous T-cell lymphoma, Se?zary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome
Clinical Study IdentifierNCT02840747
SponsorColumbia University
Last Modified on20 March 2021

Eligibility

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 Sezary Syndrome (SS) or stage IV B CTCL as defined by blood involvement on flow cytometry or morphology: (1) 1000/L Sezary 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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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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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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