Lymphoma, T-Cell, CutaneousNCT02840747
Tissue Repository: CTCL Collection Protocol
An observational study of Lymphoma, T-Cell, Cutaneous and Lymphomatoid Papulosis, run by Columbia University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous, Lymphomatoid Papulosis, Sézary Syndrome
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Larisa J. Geskin, MD contact
Brigit Lapolla contact
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Larisa J. Geskin, MD, 212-305-5293, ljg2145@cumc.columbia.edu
Brigit Lapolla, bl2963@cumc.columbia.edu
About this study
Official title: A Tissue Repository for the Collection of Samples From Patients With Cutaneous T Cell Lymphoma and Healthy Volunteers
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.
Read the 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.
- Keywords
- Lymphomatoid Papulosis, Sézary Syndrome, T-Cell Lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Lymphomatoid Papulosis, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of biological specimen collections
This is a collection protocol to establish a tissue repository for samples from patients with CTCL.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, CutaneousStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larisa J. Geskin, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840747
- Sponsor's protocol ID
- AAAQ8751
- Status last verified
- Nov 2025
- First submitted
- 15 Jul 2016
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tissue Repository for the Collection of Samples From Patients With Cutaneous T Cell Lymphoma and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02840747
- Acronym / sponsor ID
- AAAQ8751
- Keywords
- Lymphomatoid Papulosis, Sézary Syndrome, T-Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (7 listed)
- 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.
- Matched for sex, and age +/- 10 years.
Key exclusion criteria (7 listed)
- 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.
- Previous history of CTCL, SS, LYP, or any lymphoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of biological specimen collections
Time frame: 2 years
This is a collection protocol to establish a tissue repository for samples from patients with CTCL.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Larisa J. Geskin, MD contact
Brigit Lapolla contact
Larisa J. Geskin, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, T-Cell, Cutaneous and Lymphomatoid Papulosis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Larisa J. Geskin, MD (ljg2145@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of biological specimen collections (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.