Promoting Diagnosis and Management of AL in Italy (ProDigALIty)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Azienda Ospedaliera Policlinico Consorziale
RECRUITING
Bari
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
RECRUITING
Catania
Fondazione Irccs Policlinico San Matteo
RECRUITING
Pavia
EMATOLOGIA - Città della Scienza e Salute - Torino
RECRUITING
Torino
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 760
Treatments
Patients with MGUS and aFLCR and with SMM
Part A: Patients with MGUS and aFLCR and patients with SMM undergoing an active, biomarker-based screening of presymptomatic amyloid organ involvement.~Part B: Newly diagnosed patients with AL amyloidosis identified through Part A or with clinically overt AL amyloidosis evaluated in the frame of routine clinical assessments and referred to the Amyloidosis Research and Treatment Center in Pavia or managed locally at the participating Italian Hematologic Departments
Sponsors
Leads: Fondazione IRCCS Policlinico San Matteo di Pavia

This content was sourced from clinicaltrials.gov