NCT02840747 · Columbia University
Tissue Repository: CTCL Collection Protocol
What this study is about
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.
View original scientific 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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 4, 2025 · Source of record for eligibility and locations