An observational study in Ovarian Cancer, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to female participants. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
Identify any significant differences in terms of drug response and survival between the different possible alterations in the BRCA1/2 genes, in order to stratify ovarian cancer patients with a view to increasingly personalised and thus effective therapy.
Ovarian carcinoma (OC) is the leading cause of death among gynaecological neoplasms. It is, in fact, a neoplasm that is not very frequent but highly lethal: in Emilia-Romagna, the incidence is about 17 cases per 100,000 inhabitants and the mortality rate is around 15 cases per 100,000, with a very high mortality/incidence ratio (0.83). The high mortality rate is mainly due to the fact that, due to the non-specific and late symptoms, 75-80% of patients arrive at the diagnosis at an advanced stage of the disease (III-IV), characterised by a 5-year survival of less than 25%.
The primary therapeutic approach for this tumour is a combination of debulking surgery and platinum-based chemotherapy generally associated with taxanes, while as far as maintenance therapies are concerned, PARP inhibitors (PARPi), drugs capable of blocking a DNA repair mechanism alternative to that of homologous recombination, have been gaining in importance in recent years. They have proved particularly effective in tumours that present alterations in the BRCA1 and BRCA2 genes, which are key players in homologous recombination. For this reason, the detection of mutations in the BRCA1 and BRCA2 genes is predictive of the efficacy of PARPi maintenance therapy and, consequently, as of 2015, the BRCA test has been indicated in all women newly diagnosed with ovarian cancer (excluding borderline and mucinous forms), possibly from tumour tissue, given the evidence that in addition to constitutional (inherited) variants, somatic variants (acquired and tumour-confined), present in about 9%, are also associated with a PARPi benefit.
Recent data, however, have challenged the assumption that functionally significant variants for which a predisposing role has been demonstrated for hereditary breast and ovarian cancers are necessarily predictive of drug response. Furthermore, the fact that somatic mutations are present in only a limited fraction of the DNA copies analysed in a tumour suggests that there may be residual BRCA activity that compromises effective PARPi activity.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
From 2012 to the end of 2021, 869 patients underwent BRCA testing at the UOC of Medical Genetics of the IRCCS AOU of Bologna Policlinico S.Orsola 869 patients with CO, almost all of whom have given informed consent to the acquisition of clinical documentation relating to their case and to the use of their data for scientific purposes and about half of them were taken on for a period of at least 1 year at the Medical Oncology - Zamagni and/or the Gynaecological Oncology - De Iaco. The investigators estimated a sample of about 300 patients.
Exclusion Criteria:
Patients must have been diagnosed with ovarian carcinoma by 31/12/2021, have undergone BRCA testing at the UOC of Medical Genetics of the IRCCS AOU of Bologna Policlinico S. Orsola by 31/12/2021 and have been taken on for follow-up and/or treatment at the Medical Oncology - Zamagni and/or Gynaecological Oncology - De Iaco of the IRCCS Azienda Ospedaliero-Universitaria (AOU) of Bologna for a period of time of at least 1 year and by 31/12/2021 and for a minimum period of 6 months.
Patients must have been diagnosed with ovarian carcinoma by 31/12/2021, have undergone BRCA testing at the UOC of Medical Genetics of the IRCCS AOU of Bologna Policlinico S. Orsola by 31/12/2021 and have been taken on for follow-up and/or treatment at the Medical Oncology - Zamagni and/or Gynaecological Oncology - De Iaco of the IRCCS Azienda Ospedaliero-Universitaria (AOU) of Bologna for a period of time of at least 1 year and by 31/12/2021 and for a minimum period of 6 months.
Differences in BRCA1/2 status for predictive response to chemotherapy
The primary objective of the study is to clarify whether differences in the status of BRCA1/2 (presence/absence of germline and/or somatic) may be predictive in the response to chemotherapy and survival of patients with ovarian cancer.
Time frame: 12 months
Differences in response to chemotherapy based on BRCA variant
The secondary objective is to determine whether among the variant carriers germline and/or somatic pathogenesis of BRCA1/2 differences exist in terms of response to chemotherapy and survival based on the specific variant found.
Time frame: 12 months
Plan to share: No
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IRCCS Azienda Ospedaliero-Universitaria di Bologna