Local Registry of Primary Cutaneous T-cell Lymphomas | NCT07160023

Studies
Local Registry of Primary Cutaneous T-cell Lymphomas

NCT07160023

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Status

Recruiting

Last Update Posted

Sep 8, 2025Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Primary Cutaneous T-cell Lymphomas NCT Number

Interventions

Not provided

Countries

Italy

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

Feb 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

Oct 12, 2023Actual

Primary Completion Date

Oct 12, 2033Estimated

Completion Date

Oct 12, 2033Estimated

First Submitted Date

Feb 17, 2025

First Submission Date that Met QC Criteria

Aug 29, 2025

First Posted Date

Sep 8, 2025Actual

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

Aug 29, 2025

Last Update Posted Date

Sep 8, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Valeria Brazzelli, Principal Investtigator, Fondazione IRCCS Policlinico San Matteo di PaviaPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Policlinico San Matteo di PaviaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with primary cutaneous T-cell lymphoma		Patients with primary cutaneous T-cell lymphoma attending the Dermatology Unit Outpatient Clinics

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevalence of cutaneous T-cell lymphoma (CTCL) variants	The prevalence and the exact binomial 95% CI will be presented.	October 2033

Secondary Outcomes

Measure	Description	Time Frame
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.	October 2033

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

primary cutaneous T-cell lymphoma attending the outpatient clinics of the Dermatology Unit in Pavia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with primary cutaneous T-cell lymphoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Valeria Brazzelli, MD	Contact	0382503794		v.brazzelli@smatteo.pv.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SC Dermatologia, Fondazione IRCCS Policlinico San Matteo	Recruiting	Pavia	Pavia	27100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided