Clinical trial NCT06781437: Retrospective Observational Study of Italian Cohort of Lymphoma Patients (RETRO-LYMPH)
Official title: Studio Osservazionale Retrospettivo Di Coorte Italiana Di Pazienti Con Linfoma (RETRO-LYMPH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoproliferative Syndrome, Autoimmune
Lymphoma
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 5500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lymphoma / lymphoproliferative syndrome between January 1980 and September 2021

Brief summary: observational, non-interventional, retrospective, single-center study focusing on patients with lymphoma / lymphoproliferative syndrome between January 1980 and September 2021

Detailed description: observational, non-interventional, retrospective, single-center study focusing on patients with lymphoma / lymphoproliferative syndrome between January 1980 and September 2021.

Study objectives are to enrich the data on the prognostic role of clinical and epidemiological factors associated with clinical and epidemiological data of patients;

* to identify the factors that affect the evolution of the disease, such as lifestyle and occupational factors, as well as the type of treatment;
* to provide a platform for future research projects;
* Description of the various therapies that have occurred over time, duration of treatment, causes of interruption of treatment, responses;
* Description of the adverse events / safety of the various therapies for lymphoma and lymphoproliferative syndromes;
* Patient survival. Descriptive analyses will be conducted by tabulating frequency distributions and percentages and mean and median values, standard deviations, quartiles and extreme values for continuous variables. Progression-free survival, disease-free survival and overall survival will be examined using Kaplan-Meier point estimates

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years of enrollment
* Diagnosis of lymphoma or lymphoproliferative syndrome between January 1980 and September 2021
* Signature of the informed consent form where applicable

Exclusion Criteria:

* none

Primary outcomes:
measure: Incidence and prevalence of lymphomas/lymphoproliferative syndromes referred to the Centre between January 1980 and September 2021
timeFrame: through study completion, an average of 6 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 6 years
measure: event free survival (EFS)
timeFrame: through study completion, an average of 6 years
measure: Lymphoma specific survival (LSS)
timeFrame: through study completion, an average of 6 years
measure: Progression Free Survival (PFS)
timeFrame: through study completion, an average of 6 years
measure: Net survival (5 years)
timeFrame: through study completion, an average of 6 years
measure: Response rate (5 years)
timeFrame: through study completion, an average of 6 years
measure: Duration of Response (DoR)
timeFrame: through study completion, an average of 6 years
measure: time to next anti-lymphoma treatment (TTNLT)
timeFrame: through study completion, an average of 6 years
measure: Duration of survival after progression
timeFrame: through study completion, an average of 6 years
measure: lymphoma transformation frequency
timeFrame: through study completion, an average of 6 years
measure: Frequency of secondary neoplasy
timeFrame: through study completion, an average of 6 years
measure: frequency of other chronic diseases
timeFrame: through study completion, an average of 6 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References: