Validation of immune biomarkers for ovarian cancer treatment response
Prospective Cohort Study for Validation of Predictive Immune Biomarkers of Response to PAPR Inhibitors
Yonsei University · NCT05640024
This study is testing if certain immune markers in the blood can help predict how well ovarian cancer patients will respond to a specific treatment called PARP inhibitors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 54 (estimated) |
| Ages | 19 Years to 85 Years |
| Sex | Female |
| Sponsor | Yonsei University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05640024 on ClinicalTrials.gov |
What this trial studies
This study aims to validate predictive immune biomarkers that may indicate how ovarian cancer patients respond to PARP inhibitors, which are increasingly used as maintenance therapy. Researchers will collect serial blood samples from patients before and after starting treatment to analyze changes in specific immune cells, particularly CD8 and regulatory T cells. By assessing these dynamic immunological changes, the study seeks to identify reliable biomarkers that could enhance treatment outcomes for high-risk patients. The findings could lead to the development of new therapeutic targets.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced or recurrent epithelial ovarian cancer who have responded to their last platinum-based chemotherapy and are about to start PARP inhibitor maintenance therapy.
Not a fit: Patients who do not have a BRCA mutation status result or those who refuse to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment personalization for ovarian cancer patients, potentially leading to better survival outcomes.
How similar studies have performed: While this approach is based on previous findings regarding immune changes during PARP inhibitor therapy, the specific validation of these biomarkers in a prospective cohort is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathological diagnosis of epithelial ovarian cancer, 2. Presence of germline or somatic BRCA mutational status result, 3. Advanced or recurrent ovarian cancer patients who responded to their most recent platinum-based chemotherapy and plan to start PARPi (olaparib or niraparib) maintenance therapy. Exclusion Criteria: 1. Patients who refuse to participate, 2. Patients having difficulty understanding the protocol due to language barrier
Where this trial is running
Seoul
- Yonsei University Health System, Severance Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Jung-Yun Lee — Yonsei University College of Medicine Department of Obstetrics and Gynecology
- Study coordinator: Jung-Yun Lee
- Email: jungyunlee@yuhs.ac
- Phone: 82-2-2228-2237
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.
Conditions: Ovarian Cancer