RecruitingNCT02840747
Tissue Repository: CTCL Collection Protocol
A Tissue Repository for the Collection of Samples From Patients With Cutaneous T Cell Lymphoma and Healthy Volunteers
Sponsor
Columbia University
Enrollment
400 participants
Start Date
Jul 1, 2016
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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.
- 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 Criteria7
- 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.
- 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02840747