Actively Recruiting
Mutational Landscape of Women with Metastatic Ovarian Cancer Before and During PARP Inhibitor Maintenance Treatment and Incidence of Therapy-related Hematological Neoplasms
Led by European Institute of Oncology · Updated on 2025-01-20
157
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the genetic changes in women with advanced ovarian cancer who are treated with PARP inhibitors, which are drugs targeting DNA repair defects in tumors. The study focuses on therapy-related acute myeloid leukemia and myelodysplasia as potential late complications from platinum-based chemotherapy and PARP inhibitor treatment. It investigates how pre-existing genetic mutations in blood cells might influence the development of these complications over time. Participants will provide samples of buccal cells, peripheral blood, and optionally bone marrow cells and biopsies for detailed genetic and cellular analyses. These analyses include identifying germline mutations, detecting clonal hematopoiesis of indeterminate potential (CHIP), and assessing mutations related to myeloid malignancies. Sampling occurs before starting PARP inhibitor treatment and every six months during treatment, with additional evaluations if blood abnormalities develop. Throughout the study, participants will have regular blood count monitoring monthly during PARP inhibitor maintenance. In case of blood abnormalities, treatment may be paused and further bone marrow and blood analyses performed. Researchers will assess the incidence of genetic events over eight years, monitor survival, and evaluate the impact of treatment on blood cell populations. The total participation duration spans several years with ongoing clinical and laboratory assessments.
CONDITIONS
Brief Title
Genetic Landscape in Women with Metastatic Ovarian Cancer Before and During Treatment with PARP Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with advanced ovarian cancer
- In complete or partial remission after surgery
- Eligible for oral PARP inhibitors as first line with chemotherapy or as maintenance therapy
- Age 18 years or older
You will not qualify if you...
- Presence of blood cell count abnormalities before starting PARP inhibitor treatment
- Bone marrow infiltration by ovarian epithelial carcinoma cells
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before treatment
Participants provide buccal cells, peripheral blood cells, and optionally bone marrow cells and bone marrow biopsy samples for genetic and cellular analyses before starting PARP inhibitor treatment.
1 visit (in-person) with sample collection
Duration - Up to 8 years
Participants receive oral PARP inhibitor treatment and undergo blood count examinations monthly to monitor for blood count abnormalities or hematological neoplasms during treatment.
Monthly visits for clinical and blood count examination
Duration - Repeated every 6 months during treatment
Every 6 months during PARP inhibitor treatment, peripheral blood cells are analyzed to detect and monitor clonal hematopoiesis of indeterminate potential (CHIP) and other genetic changes.
Visits every 6 months with blood sample collection
Duration - Variable, depending on abnormality resolution
If blood count abnormalities appear, treatment may be suspended and participants undergo intensified monitoring including blood counts every 2 weeks and further bone marrow and peripheral blood analyses if abnormalities persist or worsen.
Blood count visits every 2 weeks, additional bone marrow and blood analyses as needed
Trial Site Locations
Total: 1 location
1
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
Research Team
F
Federica Gigli
F
Fulvia Fusar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here