Collection of tissue samples from patients with Cutaneous T-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect and store tissue samples from patients diagnosed with Cutaneous T-cell lymphoma (CTCL) and related conditions, such as Lymphomatoid Papulosis and Sézary Syndrome. The goal is to establish a tissue repository that will facilitate future research into the changes occurring in T cells associated with these diseases. By comparing samples from affected patients and healthy controls, researchers hope to gain insights that could lead to improved treatments. The study will also include control patients to enhance the understanding of the disease mechanisms.

Why it matters

Who can join: the full rules

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 it's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Larisa J. Geskin, MD — Columbia University
• Study coordinator: Larisa J. Geskin, MD
• Email: ljg2145@cumc.columbia.edu

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.