Characterizing ovarian cancer patients based on genetic factors
Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype - A Prospective Observational Study
This study looks at how genetic factors affect the treatment responses of women with ovarian cancer to see if they respond differently to standard chemotherapy over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Nordic Society of Gynaecological Oncology - Clinical Trials Unit Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (København Ø, Region Sjælland) |
| Trial ID | NCT05574673 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze a large cohort of patients with epithelial ovarian cancer who are receiving standard care treatment. It focuses on the distribution of patients based on their BRCA1/2 and homologous recombination deficiency (HRD) status. The study is divided into two observational periods: the first assesses patient responses to first-line chemotherapy, while the second characterizes long-term and short-term responders over a maximum of 36 months. Clinical samples will also be collected for further analysis.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with newly diagnosed, histologically confirmed epithelial ovarian cancer at FIGO stage I-II with BRCA1/2 mutations or stage III-IV of any histology.
Not a fit: Patients with non-epithelial ovarian cancer, borderline tumors, or those with FIGO stage I-II BRCA wild-type ovarian cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of ovarian cancer responses to treatment based on genetic profiles, leading to more personalized therapies.
How similar studies have performed: Other studies focusing on genetic profiling in ovarian cancer have shown promising results, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients are eligible to be included in the study, if all the following inclusion criteria are met: * Patients with newly diagnosed histologically confirmed epithelial ovarian cancer: * FIGO stage I-II with a known BRCA1/2 mutation (germline/gBRCA or somatic/tBRCA) * FIGO stage III-IV of any histology * Women aged ≥18 years of age at the time of diagnosis * Patients intended for platinum-based chemotherapy treatment * Patients capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol * Patients consent to provide archival tumor tissue sample Patients are ineligible to be included in the study, if any of the exclusion criteria are met: * Non-epithelial ovarian cancer, borderline tumors, or mucinous histology * Patients with FIGO stage I-II, BRCAwt ovarian cancer
Where this trial is running
København Ø, Region Sjælland
- Rigshospitalet — København Ø, Region Sjælland, Denmark (Recruiting)
Study contacts
- Study coordinator: Kristine Madsen, MD
- Email: kristine.madsen.01@regionh.dk
- Phone: 004535453311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.