Lymphoproliferative Syndrome, AutoimmuneRETRO-LYMPHNCT06781437
Retrospective Observational Study of Italian Cohort of Lymphoma Patients (RETRO-LYMPH)
An observational study of Lymphoproliferative Syndrome, Autoimmune and Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
observational, non-interventional, retrospective, single-center study focusing on patients with lymphoma / lymphoproliferative syndrome between January 1980 and September 2021 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoproliferative Syndrome, Autoimmune, Lymphoma
- How many people
- 5,500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lymphoma / lymphoproliferative syndrome between January 1980 and September 2021
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, 40138
Pier Luigi Zinzani, MD, +390512143680, pierluigi.zinzani@unibo.it
Alessandro Broccoli, MD, +390512143680, Alessandro.broccoli@studio.unibo.it
About this study
Official title: 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
Read the 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
- Conditions
- Lymphoproliferative Syndrome, Autoimmune, Lymphoma
- Medical subject headings
- Autoimmune Lymphoproliferative Syndrome, Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and prevalence of lymphomas/lymphoproliferative syndromes referred to the Centre between January 1980 and September 2021
Incidence and prevalence
Measured: through study completion, an average of 6 years
Secondary outcomes (12)
Overall Survival (OS)
Overall Survival (OS)
Measured: through study completion, an average of 6 years
event free survival (EFS)
event free survival (EFS)
Measured: through study completion, an average of 6 years
Lymphoma specific survival (LSS)
Lymphoma specific survival (LSS)
Measured: through study completion, an average of 6 years
Progression Free Survival (PFS)
Progression Free Survival (PFS)
Measured: through study completion, an average of 6 years
Net survival (5 years)
Net survival
Measured: through study completion, an average of 6 years
Response rate (5 years)
Response rate
Measured: through study completion, an average of 6 years
Duration of Response (DoR)
Duration of Response (DoR)
Measured: through study completion, an average of 6 years
time to next anti-lymphoma treatment (TTNLT)
time to next anti-lymphoma treatment (TTNLT)
Measured: through study completion, an average of 6 years
Duration of survival after progression
Duration of survival after progression
Measured: through study completion, an average of 6 years
lymphoma transformation frequency
lymphoma transformation frequency
Measured: through study completion, an average of 6 years
Frequency of secondary neoplasy
Frequency of secondary neoplasy
Measured: through study completion, an average of 6 years
frequency of other chronic diseases
frequency of other chronic diseases
Measured: through study completion, an average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Feb 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoproliferative Syndrome, AutoimmuneStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Luigi Zinzani, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781437
- Sponsor's protocol ID
- RETRO-LYMPH
- Acronym
- RETRO-LYMPH
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Osservazionale Retrospettivo Di Coorte Italiana Di Pazienti Con Linfoma (RETRO-LYMPH)
- ClinicalTrials.gov ID
- NCT06781437
- Acronym / sponsor ID
- RETRO-LYMPH / RETRO-LYMPH
- Conditions
- Lymphoproliferative Syndrome, Autoimmune, Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lymphoma / lymphoproliferative syndrome between January 1980 and September 2021
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
12 secondary outcomes
Overall Survival (OS)
Time frame: through study completion, an average of 6 years
event free survival (EFS)
Time frame: through study completion, an average of 6 years
Lymphoma specific survival (LSS)
Time frame: through study completion, an average of 6 years
Progression Free Survival (PFS)
Time frame: through study completion, an average of 6 years
Net survival (5 years)
Time frame: through study completion, an average of 6 years
Response rate (5 years)
Time frame: through study completion, an average of 6 years
Duration of Response (DoR)
Time frame: 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
Duration of survival after progression
Time frame: through study completion, an average of 6 years
lymphoma transformation frequency
Time frame: through study completion, an average of 6 years
Frequency of secondary neoplasy
Time frame: through study completion, an average of 6 years
frequency of other chronic diseases
Time frame: through study completion, an average of 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pier Luigi Zinzani, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoproliferative Syndrome, Autoimmune and Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pier Luigi Zinzani, MD (+390512143680, pierluigi.zinzani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.