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Tissue Repository: CTCL Collection Protocol

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ClinicalTrials.gov Identifier: NCT02840747
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Larisa Geskin, Columbia University

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.

Condition or disease
Lymphoma, T-Cell, Cutaneous Lymphomatoid Papulosis Sézary Syndrome

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Tissue Repository for the Collection of Samples From Patients With Cutaneous T Cell Lymphoma and Healthy Volunteers
Study Start Date : July 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Group/Cohort
Patients with CTCL
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
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
Skin biopsies, blood samples, skin swabs, nasal swabs, cheek epithelium swabs, fecal samples and urine samples may be collected from healthy volunteers.



Primary Outcome Measures :
  1. Number of biological specimen collections [ Time Frame: 2 years ]
    This is a collection protocol to establish a tissue repository for samples from patients with CTCL.


Biospecimen Retention:   Samples With DNA
Skin biopsies, swabs (skin, cheek epithelium, nasal), samples of blood, fecal and urine.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840747


Contacts
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Contact: Larisa Geskin, MD ljg2145@cumc.columbia.edu
Contact: Grace Ulerio gu2102@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Larisa J Geskin, MD    212-305-5293    ljg2145@cumc.columbia.edu   
Contact: Grace Ulerio       gu2102@cumc.columbia.edu   
Principal Investigator: Larisa J Geskin, MD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Larisa Geskin, MD Columbia University
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Responsible Party: Larisa Geskin, Associate Professor of Dermatology in Medicine at the Columbia U, Department of Dermatology, Columbia University
ClinicalTrials.gov Identifier: NCT02840747    
Other Study ID Numbers: AAAQ8751
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Larisa Geskin, Columbia University:
Lymphomatoid Papulosis
Sézary Syndrome
T-Cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Sezary Syndrome
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphomatoid Papulosis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin