Status:
NOT_YET_RECRUITING
Clinical Validation of Sophia Genetics Assay
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Ovarian Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Next-generation sequencing (NGS) technologies have revolutionized the field of genomics, enabling rapid and cost-effective analysis of DNA and RNA . Among NGS methods, Illumina sequencing is the most ...
Eligibility Criteria
Inclusion
- Samples from patients with hereditary breast and ovarian cancer (HBOC), Lynch syndromes, and intestinal polyposis that will undergo genetic testing with commercial solutions provided by Sophia Genetics and sequenced on Illumina;
- Samples from patients with rare and hereditary disorders that have been profiled with commercial solutions provided by Sophia Genetics and sequenced on Illumina;
- Samples of patients for whom a report of the results is available;
- Samples of patients who have previously consented and are aware if their genomic results.
Exclusion
- patients for whom blood, DNA or tissue samples are not available for analysis;
- samples that do not pass the quality check, set as DNA concentration, DNA integrity, library concentration and quality;
- samples for which consent for future analysis has not be given.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT07160010
Start Date
September 15 2025
End Date
December 31 2026
Last Update
September 8 2025
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