Network for early diagnosis and management of AL amyloidosis in Italy
Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
This study is trying to set up a network in Italy to help doctors find AL amyloidosis earlier in patients who are at risk, so they can get treatment sooner and improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 760 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 4 sites (Bari and 3 other locations) |
| Trial ID | NCT06383143 on ClinicalTrials.gov |
What this trial studies
This initiative aims to create a network of Italian Hematologic Departments linked to the Amyloidosis Research and Treatment Center in Pavia. It focuses on implementing a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis in at-risk patients, including those with monoclonal gammopathy of undetermined significance and smoldering multiple myeloma. The project also seeks to facilitate patient referrals for ongoing clinical studies and to explore novel diagnostic technologies. By addressing the late diagnosis of AL amyloidosis, the study aims to improve patient outcomes through timely intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of MGUS with altered free light chain ratio or smoldering multiple myeloma, as well as treatment-naïve patients with systemic AL amyloidosis.
Not a fit: Patients with symptomatic monoclonal gammopathies or those who have previously received treatment for AL amyloidosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could lead to earlier diagnosis and better management of AL amyloidosis, potentially improving survival rates.
How similar studies have performed: While the approach of establishing a dedicated network for early diagnosis is innovative, similar studies have shown promise in improving outcomes for patients with rare diseases through early intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
PART A Inclusion Criteria: * 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. Exclusion Criteria: * Diagnosis of symptomatic monoclonal gammopathies; * Previous treatment for monoclonal gammopathies. PART B Inclusion criteria: * 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. Exclusion criteria: * non-AL amyloidosis; * previous treatment for AL amyloidosis.
Where this trial is running
Bari and 3 other locations
- Azienda Ospedaliera Policlinico Consorziale — Bari, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco — Catania, Italy (Recruiting)
- Fondazione Irccs Policlinico San Matteo — Pavia, Italy (Recruiting)
- EMATOLOGIA - Città della Scienza e Salute - Torino — Torino, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.