Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06785077

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Genetic and Blood Sample Analysis Before Treatment

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

PARP Inhibitor Maintenance Treatment and Monitoring

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

Peripheral Blood Analysis Every 6 Months During Treatment

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

Evaluation After Blood Count Abnormalities

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

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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

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