NCT06383143 Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
| NCT ID | NCT06383143 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | AL Amyloidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 760 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 760 participants in total. It began in 2023-05-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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.
Frequently Asked Questions
Who can join the NCT06383143 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying AL Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06383143 currently recruiting?
Yes, NCT06383143 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fondazione IRCCS Policlinico San Matteo di Pavia to inquire about joining.
Where is the NCT06383143 trial being conducted?
This trial is being conducted at Bari, Italy, Catania, Italy, Pavia, Italy, Torino, Italy.
Who is sponsoring the NCT06383143 clinical trial?
NCT06383143 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 760 participants.