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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