Anonymization of Clinical Data From Pseudonymized Databases Collected as Part of Previus Clinical Trials on Multiple Myeloma

NCT ID: NCT07283224

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-01-01

Brief Summary

This is a retrospective, observational, single-center study conducted at the Hematology Unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The study aims to integrate genomic, clinical, and imaging data-all previously collected and pseudonymized-from earlier spontaneous studies carried out by the Hematology Unit. The main goal is to explore how genetic, clinical, and imaging features relate to disease outcomes and to develop predictive models using artificial intelligence (AI) and machine learning (ML). These models may help forecast disease progression and treatment response in the future. By combining different types of data, the research team hopes to develop new methods to predict disease progression and treatment outcomes. No new procedures, tests, or patient visits are required for this study. All the information analyzed will come from existing data collected as part of past clinical practice or previous research projects. Once anonymized, it will no longer be possible to identify individual patients. The anonymized dataset will be securely developed and stored by the bioinformatics team at the Hematology Unit of IRCCS AOUBO.

Conditions

Myeloma Multiple

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Signed Informed Consent
• Patients with confirmed diagnosis of MM, previously enrolled in spontaneous trial conducted at the UOC Ematologia, IRCCS AOU di Bologna, from 2021, for whom pseudonymized datasets are already available at the start of this study.

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Carolina Terragna

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS AOU Policlinico Sant'Orsola

Bologna, Bo, Italy

Countries

Italy

Central Contacts

Carolina Terragna, MD

Role: CONTACT

carolina.terragna@unibo.it

0512143831

Facility Contacts

Carolina Terragna, MD

Role: primary

carolina.terragna@unibo.it

0512143680

Other Identifiers

AnonyMM-AI

Identifier Type: -

Identifier Source: org_study_id