National Epidemiology of Cutaneous Lymphomas

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma With Cutaneous Involvement

Detailed Description

The primary objective of this multicenter, national, exploratory observational study is to establish a comprehensive epidemiological map of primary cutaneous lymphomas (PCLs) within the Italian territory, addressing the current lack of a centralized national registry. PCLs are defined as a heterogeneous group of extranodal lymphomas that present exclusively in the skin at the time of diagnosis and remain confined to the skin for at least six months thereafter. This study investigates the incidence and prevalence of these rare malignancies, which are characterized by distinct clinical, histopathological, immunophenotypic, and molecular profiles, noting that cutaneous T-cell lymphomas generally exhibit a higher frequency than B-cell variants. By utilizing a combined retrospective and prospective cohort design, the investigators aim to identify potential correlations between the onset of cutaneous lymphoma and various external factors, including geographic clusters of high or low incidence and exposure to environmental pollutants. The retrospective phase involves a systematic review of medical records for patients diagnosed between January 1, 2018, and December 31, 2022, while the prospective phase entails the enrollment of new patients over a three-year period following Institutional Review Board approval.

The study population consists of approximately 1,000 patients across participating Italian dermatology departments, with the Dermatology Unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna serving as the coordinating center. Eligible participants include male and female patients older than two years of age with a confirmed diagnosis of cutaneous lymphoma who provide informed consent. Clinical data collection is integrated into standard care pathways, encompassing detailed medical histories, prior and current therapeutic interventions, laboratory results, and specialized diagnostic examinations. These data points are utilized to calculate the absolute frequency of PCLs based on center-specific patient volumes and to stratify various lymphoma subgroups by age, sex, and ethnicity. Secondary endpoints focus on identifying clinical associations between specific comorbidities and disease onset, as well as evaluating longitudinal treatment responses and clinical outcomes over a two-year follow-up period.

Data management is conducted through the REDCap (Research Electronic Data Capture) electronic platform to ensure pseudonymization and secure storage. Statistical analysis is performed by an independent statistician using descriptive statistics including means, medians, and standard deviations for continuous variables, alongside frequencies and percentages for categorical data. Comparative analyses employ Chi-square or Fisher's exact tests for categorical variables, and Student's t-test, ANOVA, or Mann-Whitney U tests for continuous variables, depending on the distribution of the data. This rigorous methodological framework is designed to provide high-quality evidence regarding the clinico-pathological characteristics of PCLs in Italy, ultimately aiming to improve clinical practice and public health strategies through peer-reviewed publications and scientific dissemination.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Alessandro Pileri, MD; Phone Number: 0512144841; Email: alessandro.pileri2@unibo.it

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40138
      • Recruiting
      • IRCSS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Alessandro Pileri, MD; Phone Number: 0512144841; Email: alessandro.pileri2@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2025
• Primary Completion (Estimated): May 13, 2028
• Study Completion (Estimated): May 13, 2030

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Epidemiology
• Other Study ID Numbers: EPI.DERM.LINFOMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No