Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06785077

Genetic and Mutational Changes in Women with Metastatic Ovarian Cancer Before and During Treatment with PARP Inhibitors Incidence of Therapy-related Blood Disorders and Monitoring

Led by European Institute of Oncology · Updated on 2025-01-20

157

Participants Needed

1

Research Sites

395 weeks

Total Duration

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AI-Summary

What this Trial Is About

Therapy-related acute myeloid leukemia and myelodysplasia can occur as late complications in women treated for epithelial ovarian cancer, especially after multiple cycles of platinum-based chemotherapy. This study explores how PARP inhibitors, used in treating ovarian cancers with BRCA1/2 mutations, might influence the development of blood cell mutations and related blood disorders. Researchers are investigating the genetic landscape before and during treatment to understand the risk and development of therapy-related blood cancers. Participants will undergo detailed genetic and cellular analyses using samples from buccal cells, peripheral blood, bone marrow aspirates, and biopsies. These tests include morphological assessments, immunophenotyping, cytogenetics, and advanced sequencing techniques to detect clonal hematopoiesis and mutations linked to blood cancers. Peripheral blood samples will be analyzed every six months during PARP inhibitor therapy, with optional bone marrow evaluations in selected patients. Throughout treatment, patients will be monitored monthly for blood count abnormalities, with further bone marrow tests if needed. The study aims to identify the incidence and characteristics of new mutations and blood disorders over an 8-year period. This comprehensive monitoring includes clinical exams, blood tests, and genetic analyses to track changes and evaluate the safety and impact of PARP inhibitors in this patient population.

CONDITIONS

Official 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
Not Eligible

You will not qualify if you...

  • Presence of blood cell count abnormalities before PARP inhibitor treatment
  • Bone marrow infiltration by epithelial ovarian cancer cells

AI-Screening

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Trial Site Locations

Total: 1 location

1

Istituto Europeo di Oncologia

Milan, Italy, 20141

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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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