RECRUITING

Tissue Repository: CTCL Collection Protocol

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Conditions

Lymphoma, T-Cell, CutaneousLymphomatoid PapulosisSézary SyndromeT-Cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-07
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02840747

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Ability to understand and willing to sign a willing informed consent document.
  4. * Age ≥ 18 years.
  5. * Matched for sex, and age +/- 10 years.
  6. * Ability to sign informed consent document.
  7. * 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.
  1. * Patients with a history of previous lymphoma other than CTCL or SS or LYP.
  2. * Medical illnesses with potential suppressive or activating impact on immune and bowel function as judged by the investigator.
  3. * Current, viable pregnancy.
  4. * Anemia with a documented hemoglobin laboratory value of \<7.5 g/dl within the past 6 months.
  5. * Previous history of CTCL, SS, LYP, or any lymphoma.
  6. * Previous history of Human Immunodeficiency Virus (HIV) infection.
  7. * Anemia with a documented hemoglobin laboratory value of \<7.5 g/dl within the past 6 months.

Contacts and Locations

Study Contact

Larisa J. Geskin, MD
CONTACT
ljg2145@cumc.columbia.edu
Brigit Lapolla
CONTACT
bl2963@cumc.columbia.edu

Principal Investigator

Larisa J. Geskin, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Larisa J. Geskin, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-07
Study Completion Date2025-01

Study Record Updates

Study Start Date2016-07
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • Lymphomatoid Papulosis
  • Sézary Syndrome
  • T-Cell Lymphoma

Additional Relevant MeSH Terms

  • Lymphoma, T-Cell, Cutaneous
  • Lymphomatoid Papulosis
  • Sézary Syndrome