Clinical trial · Observational
Tissue Repository: CTCL Collection Protocol
A Tissue Repository for the Collection of Samples From Patients With Cutaneous T Cell Lymphoma and Healthy Volunteers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, T-Cell, Cutaneous | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphomatoid Papulosis | Lymphomatoid Papulosis | ONTOLOGY_EXACT | 0.98 |
| Sézary Syndrome | Sezary Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Patients with CTCL
- description
- Skin biopsies, blood samples, skin swabs, nasal swabs, cheek epithelium swabs, fecal samples and urine samples may be collected from patients with CTCL (according to World Health Organization-European Organization for Research and Treatment of Cancer (WHO-EORTC) criteria).
- label
- Patients with benign dermatoses
- description
- Skin biopsies, blood samples, skin swabs, nasal swabs, cheek epithelium swabs, fecal samples and urine samples may be collected from patients with benign dermatoses, including but not limited to conditions such as eczema, psoriasis, and dermatitis.
- label
- Healthy Controls
- description
- Skin biopsies, blood samples, skin swabs, nasal swabs, cheek epithelium swabs, fecal samples and urine samples may be collected from healthy volunteers.
Primary outcomes (1)
- measure
- Number of biological specimen collections
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available