Genetic analysis in women with metastatic ovarian cancer during PARP inhibitor treatment
Mutational Landscape of Women Suffering from Metastatic Ovarian Cancer Before Poly (ADP-ribose) Polymerase Inhibitors Maintenance Treatment and During Treatment. Incidence of Therapy-related Hematological Neoplasms.
This study is testing how PARP inhibitor treatment affects the genes and blood cells of women with metastatic ovarian cancer to see if it leads to any serious side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 157 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT06785077 on ClinicalTrials.gov |
What this trial studies
This study investigates the genetic landscape of women with metastatic ovarian cancer who are receiving treatment with PARP inhibitors. It focuses on analyzing peripheral blood and bone marrow samples to identify potential dysplastic changes and abnormalities in hematopoietic lineages. The study aims to evaluate the impact of PARP inhibition on different cell populations and assess the risk of therapy-related acute myeloid leukemia and myelodysplasia. By utilizing advanced techniques such as multiparametric FACS analysis, the research seeks to enhance understanding of treatment effects on cancer progression.
Who should consider this trial
Good fit: Ideal candidates for this study are women with advanced ovarian cancer who are in complete or partial remission and are eligible for PARP inhibitor therapy.
Not a fit: Patients with blood cell count abnormalities or bone marrow infiltration by epithelial ovarian cancer cells may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for women with advanced ovarian cancer, potentially reducing the risk of developing secondary malignancies.
How similar studies have performed: Other studies have shown promising results with PARP inhibitors in similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Women with advanced ovarian cancer in complete or partial remission after surgery and eligible to oral PARP inhibitors as first line in association to chemotherapy or as maintenance therapy. Exclusion Criteria: * Presence of blood cell count abnormalities before PARP inhibitor treatment; * Bone marrow infiltration by EOC cells.
Where this trial is running
Milan
- Istituto Europeo di Oncologia — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Federica Gigli — Istituto Europeo di Oncologia
- Study coordinator: Federica Gigli
- Email: federica.gigli@ieo.it
- Phone: +390257489538
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.