Tissue Repository: CTCL Collection Protocol

Launched by COLUMBIA UNIVERSITY · Jul 20, 2016

Keywords

ClinConnect Summary

This clinical trial, called the Tissue Repository: CTCL Collection Protocol, is focused on understanding changes in certain immune cells known as T cells in patients with Cutaneous T-cell lymphoma (CTCL), which is a type of skin lymphoma. The main goal is to collect and store tissue samples from patients diagnosed with CTCL, Lymphomatoid Papulosis, and Sézary Syndrome for future research. Researchers will also gather samples from control patients who have similar characteristics but do not have these conditions.

To participate in this study, patients must be at least 18 years old and have a confirmed diagnosis of CTCL, Lymphomatoid Papulosis, or Sézary Syndrome, especially if they are starting or changing their treatment. Individuals with certain benign skin conditions may also be included as control participants. Participants can expect to provide tissue samples, which will be stored for further studies aimed at improving understanding and treatment of these skin lymphomas. It’s important to note that individuals with a history of other types of lymphoma or certain medical conditions may not be eligible to join the trial.

Gender

ALL

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.