Primary Cutaneous T-cell Lymphomas NCT NumberCuTLyNCT07160023
Local Registry of Primary Cutaneous T-cell Lymphomas
An observational study of Primary Cutaneous T-cell Lymphomas NCT Number, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
This registry aims to collect retrospective and prospective data on patients with primary cutaneous T-cell lymphoma who are treated at the Dermatology Clinic of the IRCCS Policlinico San Matteo Foundation. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Primary Cutaneous T-cell Lymphomas NCT Number
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 12 Oct 2023to 12 Oct 2033
- How long will I take part?
- 10 Years
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with primary cutaneous T-cell lymphoma
Who may be able to join
- primary cutaneous T-cell lymphoma attending the outpatient clinics of the Dermatology Unit in Pavia
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
SC Dermatologia, Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
Valeria Brazzelli, MD, 0382503794, v.brazzelli@smatteo.pv.it
About this study
This registry aims to collect retrospective and prospective data on patients with primary cutaneous T-cell lymphoma who are treated at the Dermatology Clinic of the IRCCS Policlinico San Matteo Foundation.
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 primary cutaneous T-cell lymphoma | Patients with primary cutaneous T-cell lymphoma attending the Dermatology Unit Outpatient Clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of cutaneous T-cell lymphoma (CTCL) variants
The prevalence and the exact binomial 95% CI will be presented.
Measured: October 2033
Secondary outcomes (3)
survival among the various subtypes of CTCL
To compare survival among the various subtypes of CTCL, the survival rate will be reported as deaths per 100 person-years; the start date of follow-up will be the diagnosis of the disease. The groups will be compared using the log-rank test and survival will be described using Kaplan-Meier curves.
Measured: October 2033
Association between clinical, histopathological and immunophenotypic characteristics of patients with cutaneous T-cell lymphoma and overall survival
A Cox model will be used to derive the hazard ratio (HR) and relative 95% CI. Harrell's c statistic will be calculated for the model's ability to discriminate. Estimates will be adjusted as far as possible for potential confounding factors.
Measured: October 2033
dermatoscopic features of cutaneous T-cell lymphomas
Descriptive statistics will be calculated for each type of cutaneous lymphoma.
Measured: October 2033
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start12 Oct 2023
- Primary completion12 Oct 2033 (estimated)
- Study completion12 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Cutaneous T-cell Lymphomas NCT NumberStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Brazzelli, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160023
- Sponsor's protocol ID
- CuTLy
- Acronym
- CuTLy
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Registry of Primary Cutaneous T-cell Lymphomas
- ClinicalTrials.gov ID
- NCT07160023
- Acronym / sponsor ID
- CuTLy / CuTLy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 12 Oct 2033 (estimated)
- Study completion
- 12 Oct 2033 (estimated)
- First posted
- 8 Sep 2025 (actual)
- 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 registry aims to collect retrospective and prospective data on patients with primary cutaneous T-cell lymphoma who are treated at the Dermatology Clinic of the IRCCS Policlinico San Matteo Foundation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with primary cutaneous T-cell lymphoma | – | –Patients with primary cutaneous T-cell lymphoma attending the Dermatology Unit Outpatient Clinics |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with primary cutaneous T-cell lymphoma
Key inclusion criteria (1 listed)
- primary cutaneous T-cell lymphoma attending the outpatient clinics of the Dermatology Unit in Pavia
Key exclusion criteria (0 listed)
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
prevalence of cutaneous T-cell lymphoma (CTCL) variants
Time frame: October 2033
The prevalence and the exact binomial 95% CI will be presented.
3 secondary outcomes
survival among the various subtypes of CTCL
Time frame: October 2033
Association between clinical, histopathological and immunophenotypic characteristics of patients with cutaneous T-cell lymphoma and overall survival
Time frame: October 2033
dermatoscopic features of cutaneous T-cell lymphomas
Time frame: October 2033
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 8 Sep 2025.
- Individual participant dataSharing planned: No
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.
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 Primary Cutaneous T-cell Lymphomas NCT Number, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 1 inclusion and 0 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 8 Sep 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 Italy. 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 Valeria Brazzelli, MD (0382503794, v.brazzelli@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of cutaneous T-cell lymphoma (CTCL) variants (time frame: October 2033). 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 8 Sep 2025.