Retrospective Observational Study of Italian Cohort of Lymphoma Patients (RETRO-LYMPH)

Recruiting

• Conditions: Lymphoproliferative Syndrome, Autoimmune; Lymphoma

• Registration Number: NCT06781437
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Study Timeline

• Study Start: 2022-02-01
• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and prevalence of lymphomas/lymphoproliferative syndromes referred to the Centre between January 1980 and September 2021	through study completion, an average of 6 years	Incidence and prevalence

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	through study completion, an average of 6 years	Overall Survival (OS)
event free survival (EFS)	through study completion, an average of 6 years	event free survival (EFS)
Lymphoma specific survival (LSS)	through study completion, an average of 6 years	Lymphoma specific survival (LSS)
Progression Free Survival (PFS)	through study completion, an average of 6 years	Progression Free Survival (PFS)
Net survival (5 years)	through study completion, an average of 6 years	Net survival
Response rate (5 years)	through study completion, an average of 6 years	Response rate
Duration of Response (DoR)	through study completion, an average of 6 years	Duration of Response (DoR)
time to next anti-lymphoma treatment (TTNLT)	through study completion, an average of 6 years	time to next anti-lymphoma treatment (TTNLT)
Duration of survival after progression	through study completion, an average of 6 years	Duration of survival after progression
lymphoma transformation frequency	through study completion, an average of 6 years	lymphoma transformation frequency
Frequency of secondary neoplasy	through study completion, an average of 6 years	Frequency of secondary neoplasy
frequency of other chronic diseases	through study completion, an average of 6 years	frequency of other chronic diseases

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna; 🇮🇹 Bologna, Italy