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

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

This study is collecting tissue samples from patients with Cutaneous T-cell lymphoma and related conditions to help researchers learn more about the disease and find better treatments.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Columbia University (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT02840747 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a clinical or histologic diagnosis of CTCL, Lymphomatoid Papulosis, or Sézary Syndrome.

Not a fit: Patients with conditions unrelated to CTCL or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to advancements in the understanding and treatment of Cutaneous T-cell lymphoma and related conditions.

How similar studies have performed: While this approach is not novel, it builds on existing methodologies for tissue collection in cancer research, which have shown success in enhancing understanding of various malignancies.

Eligibility 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.

Where this trial is running

New York, New York

• 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

Conditions: Lymphoma, T-Cell, Cutaneous, Lymphomatoid Papulosis, Sézary Syndrome, T-Cell Lymphoma