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

Hellenic Cooperative Oncology Group

Status: Completed

Conditions: Epithelial Ovarian Cancer

Treatments: Other: Tumor molecular profiling

Study type: Observational

Funder types: Other

Identifiers

NCT04716374

Ovarian_ΗΕ4G/20

Details and patient eligibility

About

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.

Enrollment: 550 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosed with epithelial ovarian cancer
• Received treatment at HeCOG-affiliated institutions
• Have signed informed consent
• With adequate tumor tissue for analysis

Trial design

550 participants in 1 patient group

Patients with epithelial ovarian cancer

Description:

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.

Treatment:

Other: Tumor molecular profiling