Clinical trial NCT04716374: Pathogenic Variants in Homologous Recombination Repair Genes in Patients With Epithelial Ovarian Cancer
Official title: Clonality of Pathogenic Variants in Homologous Recombination Repair Genes in Patients With Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian Cancer
Keywords: Epithelial ovarian cancer
Next Generation Sequencing (NGS)
Pathogenic variants
Tumor molecular profiling
Clonality
Homologous recombination repair
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 550
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 from following standard international guidelines.

In total, 501 patients with ovarian adenocarcinoma were included in the study (median age at ovarian cancer diagnosis was 58 years). Tumor histological types included predominantly high-grade serous, followed by endometrioid and clear cell carcinomas. All except 3 patients underwent surgery at initial diagnosis, most commonly total abdominal hysterectomy with bilateral salpingo-oophorectomy.

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.


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

Primary outcomes:
measure: Overall survival
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: HeCOG
name: ELENA FOUNTZILAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fountzilas E, Kotoula V, Koliou GA, Liontos M, Papadopoulou K, Giannoulatou E, Papanikolaou A, Tikas I, Chrisafi S, Mauri D, Chatzopoulos K, Fostira F, Pectasides D, Oikonomopoulos G, Aivazi D, Andrikopoulou A, Visvikis A, Aravantinos G, Zagouri F, Fountzilas G. Tumor Genotyping and Homologous Recombination Repair Gene Variants in Patients With Epithelial Ovarian Cancer: Is Pathogenic Enough? Front Oncol. 2021 Jun 1;11:683057. doi: 10.3389/fonc.2021.683057. eCollection 2021.