Italian Study of Patients with Lymphoma (LYMPH-OS)

February 3, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Italian Prospective Observational Cohort Study of Patients with Lymphoma

It is an observational, non-interventional, prospective, monocentric study, whose objective is to enroll 1500 patients with lymphoma in 5 years within the Institute of Hematology "Seragnoli".

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study is aimed at enriching the data on the prognostic role of genetic and epidemiological factors associated with clinical and epidemiological data of patients; to identify factors that influence the evolution of the disease, such as lifestyle and occupational factors, as well as the type of treatment; to document the impact of the disease on quality of life and to provide a platform for future research projects.

Study-specific questionnaires will be administered to patients, both at baseline and during follow-up, which methodologically represent a useful tool in order to achieve these objectives.

Study Type

Observational

Enrollment (Estimated)

1500

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

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero - Universitaria di Bologna
        • Contact:
          • Pier Luigi Zinzani, MD
        • Contact:
        • Contact:

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

1500 patients with lymphoma (about 500 cases of DLBCL, 360 of FL, 260 of CLL/SLL, 110 of MZL, 60 of PTCL e MCL, 40 of LPL/WM, 30 of MF and BL, and 15 of HCL e ALL)

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years at enrollment
  • Diagnosis of lymphoma within 3 months of enrollment
  • Patients may have been treated, as long as the initial diagnosis of lymphoma is within 3 months of enrollment
  • Signing of the informed consent form

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
Overall Survival (OS)
Time Frame: through study completion, an average of 5 years
From the date of diagnosis to the date of death
through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Free Survival (EFS)
Time Frame: through study completion, an average of 5 years
Time elapsed from the date of diagnosis to the date of the first event that occurred (disease progression, relapse or new treatment for lymphoma, or death)
through study completion, an average of 5 years
Lymphoma Specific Survival (LSS)
Time Frame: through study completion, an average of 5 years
Time elapsed from the date of diagnosis to the date of death from lymphoma (disease progression, relapse or new treatment for lymphoma, or death)
through study completion, an average of 5 years
Progression-Free Survival (PFS)
Time Frame: through study completion, an average of 5 years
To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment
through study completion, an average of 5 years
net survival
Time Frame: through study completion, an average of 5 years
To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment
through study completion, an average of 5 years
response rate
Time Frame: through study completion, an average of 5 years
To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment
through study completion, an average of 5 years
Duration of response
Time Frame: through study completion, an average of 5 years
To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment
through study completion, an average of 5 years
Time to next anti-lymphoma treatment (TTNLT)
Time Frame: through study completion, an average of 5 years
To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment
through study completion, an average of 5 years
Duration of survival after progression
Time Frame: through study completion, an average of 5 years
To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment
through study completion, an average of 5 years
Frequency of lymphoma transformation
Time Frame: through study completion, an average of 5 years
To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment
through study completion, an average of 5 years
Frequency of secondary cancers
Time Frame: through study completion, an average of 5 years
To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment
through study completion, an average of 5 years
Frequency of other chronic diseases
Time Frame: through study completion, an average of 5 years
To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment
through study completion, an average of 5 years
questionnarire of Quality of Life FACT-LYM (Functional Assessment of Cancer Therapy-Lymphoma): score 0 to 4
Time Frame: through study completion, an average of 5 years
questionnarire of Quality of Life FACT-LYM (Functional Assessment of Cancer Therapy-Lymphoma): score 0 to 4.questions regarding physical well-being, social/familial well-being, emotional well-being, functional well-being, additional questions specific to lymphoma
through study completion, an average of 5 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)

December 7, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LYMPH-OS

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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