Tissue Repository: CTCL Collection Protocol
Columbia University · NCT02840747
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 400
- US sites recruiting
- 1
- Study start
- July 2016
- Record last updated
- November 4, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the 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. Collection and storage of tissue samples from control patients will also be carried out.
Conditions: Lymphoma, T-Cell, Cutaneous; Lymphomatoid Papulosis; Sézary Syndrome
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Columbia University Irving Medical Center
New York, NY 10032
Site contact: Larisa J. Geskin, MD · 212-305-5293 · ljg2145@cumc.columbia.edu
Study contacts (from the official record)
- Larisa J. Geskin, MD · ljg2145@cumc.columbia.edu
- Brigit Lapolla · bl2963@cumc.columbia.edu
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