Tissue Repository: CTCL Collection Protocol
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
This protocol is for the collection of biological specimens from patients who fall into the following three groups: 1. Patients with diagnosis of cutaneous T cell lymphoma (diagnosed according to the WHO-EORTC criteria) 2. Patients with benign dermatoses, including but not limited to psoriasis, eczema, and dermatitis. 3. Healthy controls
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 3 trial groupsGroup A: Patients with CTCL
Group B: Patients with benign dermatoses
Group C: Healthy Controls
Trial outcomes
Primary outcomes
1
Number of biological specimen collections
This is a collection protocol to establish a tissue repository for samples from patients with CTCL.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov