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

January 13, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Studio Osservazionale Retrospettivo Di Coorte Italiana Di Pazienti Con Linfoma (RETRO-LYMPH)

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

5500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with lymphoma / lymphoproliferative syndrome between January 1980 and September 2021

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and prevalence of lymphomas/lymphoproliferative syndromes referred to the Centre between January 1980 and September 2021
Time Frame: through study completion, an average of 6 years
Incidence and prevalence
through study completion, an average of 6 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RETRO-LYMPH

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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