NCT06383143Recruiting
Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
The investigators plan to establish a dedicated network of Italian Hematologic Departments interconnected with the Amyloidosis Research and Treatment Center in Pavia to: 1. Implement a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis among at-risk patients, including patients with monoclonal gammopathy of undetermined significance, MGUS, and altered free light chain ratio (aFLCR), and patients with smoldering multiple myeloma (SMM) 2. Expedite and facilitate patients' referral and their enrollment in ongoing pre-clinical/clinical studies, also to reflect a broader spectrum of the real-world population of patients with AL amyloidosis in Italy; 3. Investigate the clinical utility of novel diagnostic technologies, including light chain sequencing and N-glycosylation analysis
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 760 (estimated)
- First submitted
- 19 Apr 2024
- Start date
- 1 May 2023
- Primary completion date
- 1 May 2026
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Diseases
- Amyloidosis, Multiple myeloma
- NCT number
- NCT06383143
What you commit to
- Study type: Observational
- Planned participants: 760
- From 1 May 2023 to the primary completion date, 1 May 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment for monoclonal gammopathies.
- PART B
- previous treatment for AL amyloidosis.
Other
- Diagnosis of symptomatic monoclonal gammopathies;
- non-AL amyloidosis;
Who the study is looking for
- diagnosis of MGUS with altered FLCR or SMM;
- treatment-naïve;
- age ≥18 years;
- ability to understand and willingness to sign an informed consent;
- planned follow-up at participating center.
- diagnosis of systemic AL amyloidosis;
- treatment-naïve;
- age ≥18 years;
- ability to understand and willingness to sign an informed consent;
- planned follow-up at participating center.
Criteria the registry did not label
- PART A
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Policlinico Consorziale Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| EMATOLOGIA - Città della Scienza e Salute - Torino Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.