Clonality of Pathogenic Variants in Homologous Recombination Repair Genes in Patients With Epithelial Ovarian Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epithelial Ovarian Cancer
- Sponsor
- Hellenic Cooperative Oncology Group
- Enrollment
- 550
- Primary Endpoint
- Overall survival
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Molecular alterations in Homologous Recombination Repair (HRR) genes have been associated with clinical benefit from chemotherapy and/or Poly (ADP-ribose) polymerase (PARP) inhibitors in patients with epithelial ovarian cancer. Therefore, the performance of tumor molecular profiling is currently recommended by international guidelines at initial diagnosis, among other reasons, for the modification of the treatment plan. The investigators' hypothesis was that tumor molecular profiling reveals additional parameters that can improve the predictive and prognostic role of the mere presence of HRR gene mutations. The study aimed to investigate the prognostic and predictive role of clonality of pathogenic variants in HRR genes and/or concurrent pathogenic variants in other clinically relevant genes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with epithelial ovarian cancer
- •Received treatment at HeCOG-affiliated institutions
- •Have signed informed consent
- •With adequate tumor tissue for analysis
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall survival
Time Frame: Through study completion, an average of 3 years
The time from ovarian cancer diagnosis to the date of death from any cause
Secondary Outcomes
- Progression-free survival(From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months)