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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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