National Epidemiology of Cutaneous Lymphomas

NCT07463989 | Recruiting

• 1 other identifier: EPI.DERM.LINFOMI
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale and Objective Primary cutaneous lymphomas are a rare and diverse group of cancers that start in the skin. While international data suggests an increase in cases since the 1970s, there is currently a lack of nationwide data in Italy regarding how common these diseases are and how they correlate with environmental or social factors.The main goal of this study is to create a national map of cutaneous lymphoma incidence and prevalence in Italy. Researchers want to identify if there are specific geographic areas with higher or lower numbers of cases and investigate potential links between the disease and environmental pollutants or other health conditions (comorbidities).Study Design This is a multicenter observational study that looks at both past and future data (retrospective and prospective). The study will involve approximately 1,000 patients across several Italian dermatology departments, with the IRCCS Azienda Ospedaliero-Universitaria di Bologna serving as the coordinating center.What the Study InvolvesData Collection: Researchers will review medical records from January 1, 2018, to December 31, 2022 (retrospective phase) and continue to collect data for patients enrolled over the next three years.Patient Participation: Patients will follow their standard clinical care paths. Information collected includes medical history, current and previous therapies, and laboratory results.Follow-up: Participants will be monitored for approximately two years to evaluate clinical outcomes and treatment responses.Expected Outcomes By analyzing this data, the study aims to improve clinical practice by providing a clearer understanding of how cutaneous lymphoma affects the Italian population based on age, sex, ethnicity, and location.

Conditions

Lymphoma With Cutaneous Involvement

Keywords

Epidemiology

Outcome Measures

Primary Outcomes (3)

• To identify potential correlations between cutaneous lymphoma and other factors (including potential areas of high/low incidence and correlations with environmental factors such as pollutants).

  The incidence of the various types of lymphoma across the different Italian regions; the prevalence of the various types of lymphoma across the different Italian regions

  5 years from the start of the study

• To calculate the incidence of various lymphoma subgroups and their stratification by age and sex, to identify geographical areas of high/low incidence and to describe the clinical characteristics of cutaneous lymphomas

  The incidence of the various types of lymphoma for each center; the prevalence of the various types of lymphoma for each center; the mean age at diagnosis

  5 years from the start of the study

• To identify the absolute frequency of cutaneous lymphoma based on center admissions

  The absolute frequency of the various types of cutaneous lymphoma

  5 years from the start of the study

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include both male and female patients diagnosed with cutaneous lymphoma since January 1, 2018. It is estimated that approximately 1,000 patients will be enrolled, 300 of whom are expected to be recruited from the Dermatology Unit of the IRCCS AOUBO

You may qualify if:

• Patients over 2 years of age
• Patients with cutaneous lymphoma
• Obtaining informed consent

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCSS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Central Study Contacts

Alessandro Pileri, MD

CONTACT

0512144841; alessandro.pileri2@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 11, 2026
• Study Start: May 13, 2025
• Primary Completion (Estimated): May 13, 2028
• Study Completion (Estimated): May 13, 2030
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)