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Promoting Diagnosis and Management of AL in Italy (ProDigALIty)

Recruitingn/aAges 18 Years - 99 YearsAllFondazione IRCCS Policlinico San Matteo di Pavia
NCT06383143 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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.
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What it tests

  • no intervention
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Where

4 sites
Azienda Ospedaliera Policlinico Consorziale
Bari, Italy
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Catania, Italy
Fondazione Irccs Policlinico San Matteo
Pavia, Italy
EMATOLOGIA - Città della Scienza e Salute - Torino
Torino, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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