Study on the Diagnosis and Management of CLL in Italy by GIMEMA (NCT04867915) | Clinical Trial Compass
RecruitingNot Applicable
Study on the Diagnosis and Management of CLL in Italy by GIMEMA
Italy12,500 participantsStarted 2021-10-13
Plain-language summary
retrospective and prospective multicenter observational clinical and biological data collection from all patients with newly diagnosed CLL, SLL or MBL.
retrospective cohort: all cases with a diagnosis between January 1st 2010 and August 31th 2021.
prospective cohort: all patients with a diagnosis between September 1st 2021 and September 1st 2025.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years at diagnosis
. One of the following diagnoses that meet the international diagnostic criteria (iwCLL2018 and WHO2017)
. Chronic lymphocytic leukemia (CLL)
. Small lymphocytic lymphoma (SLL)
. CLL-like monoclonal B-cell lymphocytosis (MBL)
. Retrospective cohort: CLL/SLL/MBL diagnosis between January 1st 2010 and August 31th 2021.
. Prospective cohort: CLL/SLL/MBL diagnosis between September 1st 2021 and September 1st, 2025.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Describe the diagnosis and management of CLL patients
Timeframe: at 1 year for the prospective cohort and at 4 years for the retrospective cohort
Trial details
NCT IDNCT04867915
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto