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Recruiting Observational

National Epidemiology of Cutaneous Lymphomas

NCT07463989 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-05-13
Last updated
2026-03-11

Condition(s) studied

Lymphoma With Cutaneous Involvement

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients over 2 years of age * Patients with cutaneous lymphoma * Obtaining informed consent Exclusion Criteria: * NA

Primary outcome measure(s)

  • 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). — 5 years from the start of the study
    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
  • 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 — 5 years from the start of the study
    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
  • To identify the absolute frequency of cutaneous lymphoma based on center admissions — 5 years from the start of the study
    The absolute frequency of the various types of cutaneous lymphoma

Trial sites (1)

FacilityCityRegionStatus
IRCSS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07463989 on ClinicalTrials.gov ↗ ← All trials in Italy