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
- Name: Cinzia Pellegrini, MD
- Phone Number: +390512143680
- Email: cinzia.pellegrini@aosp.bo.it
Study Contact Backup
- Name: Pier Luigi Zinzani, MD
- Phone Number: +390512143680
- Email: pierluigi.zinzani@unibo.it
Study Locations
-
-
-
Bologna, Italy, 40138
- Recruiting
- IRCCS Azienda Ospedaliero - Universitaria di Bologna
-
Contact:
- Pier Luigi ZINZANI, MD
-
Contact:
- Pier Luigi Zinzani, MD
- Phone Number: +390512143680
- Email: pierluigi.zinzani@unibo.it
-
Contact:
- Cinzia Pellegrini, MD
- Phone Number: +39 0512143680
- Email: cinzia.pellegrini@aosp.bo.it
-
-
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.
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.