Pathogenic Variants in Homologous Recombination Repair Genes in Patients With Epithelial Ovarian Cancer

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Other: Tumor molecular profiling

• Registration Number: NCT04716374
• Lead Sponsor: Hellenic Cooperative Oncology Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2013-01
• Study Completion: 2019-12
• Status Verified: 2020-12
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2021-01-18
• Last Update Submitted: 2021-01-18
• Study First Posted: 2021-01-20
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 550

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with epithelial ovarian cancer	Tumor molecular profiling	Patients with epithelial ovarian adenocarcinoma with archival tumor tissue available for analysis were identified through the Hellenic Cooperative Oncology Group (HeCOG)'s tumor repository. Patients had received treatment at HeCOG-affiliated institutions following standard international guidelines.

Primary Outcome Measures

Name	Time	Method
Overall survival	Through study completion, an average of 3 years	The time from ovarian cancer diagnosis to the date of death from any cause

Secondary Outcome Measures

Name	Time	Method
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	The time from initiation of first-line chemotherapy to the first documented progression, death from any cause or last contact, whichever occurred first