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

Epithelial Ovarian Cancer Clinical Trial

— PaVaClO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716374
• Other study ID #: Ovarian_??4G/20
• Status: Completed
• Start date: January 2004
• Est. completion date: December 2019

Study information

• Verified date: December 2020
• Source: Hellenic Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: December 2019
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• Tumor molecular profiling
Tumor tissue processing and all NGS genotyping were performed at the Laboratory of Molecular Oncology (Hellenic Foundation for Cancer Research / AUTH). Paraffin H&E sections from the retrieved tissue blocks were centrally reviewed for tumor histology and tissue adequacy for DNA extraction and were marked for macrodissection along with tumor DNA content [(former tumor cell content (TCC%)] assessment. DNA was extracted from macrodissected tissue fragments with the QIAamp® DNA mini kit (Qiagen, Hilden, Germany), measured in a Qubit fluorometer (Thermo Fisher Scientific, Paisley, UK), and genotyped with NGS in an Ion Torrent Proton sequencer (Thermo Fisher Scientific) by using a previously published custom panel (Kotoula, Lakis et al. 2019). Following stringent variant quality filtering (Kotoula, Chatzopoulos et al. 2021), 500 tumors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Cooperative Oncology Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The time from ovarian cancer diagnosis to the date of death from any cause	Through study completion, an average of 3 years
Secondary	Progression-free survival	The time from initiation of first-line chemotherapy to the first documented progression, death from any cause or last contact, whichever occurred first	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