Tissue Repository: CTCL Collection Protocol | NCT02840747

Studies
Tissue Repository: CTCL Collection Protocol

NCT02840747

Sponsor

Columbia University

Status

Recruiting

Last Update Posted

Nov 4, 2025Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Lymphoma, T-Cell, Cutaneous
Lymphomatoid Papulosis
Sézary Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Oct 2026Estimated

Completion Date

Oct 2026Estimated

First Submitted Date

Jul 15, 2016

First Submission Date that Met QC Criteria

Jul 20, 2016

First Posted Date

Jul 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2025

Last Update Posted Date

Nov 4, 2025Actual

Description Module

Brief Summary

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.

Detailed Description

CTCL is a heterogeneous group of non-Hodgkin's lymphomas characterized by chronic inflammation and accumulation of malignant T cells in the skin. In order to carry out research to expand the knowledge and develop more effective treatments, tissue samples from CTCL patients with presumed or known disorders are required and tissue samples from control patients will be required to compare the differences between affected and healthy populations.

Scientists will be able to test new ideas and new technologies that are not apparent or available at the present moment from this tissue repository in the future. This type of information will thus be of great advantage to future patients with these diseases.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with CTCL		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).
Patients with benign dermatoses		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.
Healthy Controls		Skin biopsies, blood samples, skin swabs, nasal swabs, cheek epithelium swabs, fecal samples and urine samples may be collected from healthy volunteers.

Interventions

Not provided

Measure	Description	Time Frame
Number of biological specimen collections	This is a collection protocol to establish a tissue repository for samples from patients with CTCL.	2 years

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This protocol is for the collection of biological specimens from patients who fall into the following three groups:

Patients with diagnosis of cutaneous T cell lymphoma (diagnosed according to the WHO-EORTC criteria)
Patients with benign dermatoses, including but not limited to psoriasis, eczema, and dermatitis.
Healthy controls

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Larisa J. Geskin, MD	Contact			ljg2145@cumc.columbia.edu
Brigit Lapolla	Contact			bl2963@cumc.columbia.edu

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D016410	Lymphoma, T-Cell, Cutaneous
D017731	Lymphomatoid Papulosis
D016399	Lymphoma, T-Cell