Clinical trial · Observational
The Clinical Markers for PARP Inhibitors-related Efficacy in Ovarian Cancer
A Real-world Study of Clinical Markers for PARP Inhibitors in Epithelial Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Epithelial ovarian cancer (EOC) is the most lethal gynecological malignancy. PARP inhibitors(PARPi) are an important progress in EOC treatment. The available evidence suggests that BRCAmt or HRD-positive is an effective biological marker for PARPi. However, in our previous clinical observation, it was found that the tumor burden may be the potential clinical markers PARPi. We intend to develop a real-world study to confirm the potential clinical markers and explore new clinical markers for PARPi.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Marker | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| PARP Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PARP inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ovarian cancer patients treated with PARP inhibitors
- description
- PARP inhibitors therapy until disease progression
- interventionNames
- Drug: PARP inhibitors
Primary outcomes (5)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Through study completion, an average of 1 year
- description
- ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.
- measure
- Progression Free Survival (PFS)
- timeFrame
- Through study completion, an average of 1 year
- description
- PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects join the study voluntarily and sign informed consent; 2. Female subjects are older than 18 years; 3. ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2; 4. Life expectancy≥3 months; 5. Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous or endometrioid histology; 6. Patients should test for BRCA gene and will perform test for HRD status if who harbor BRCAwt in the same laboratory designated by the researcher; 7. Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks. Exclusion Criteria: 1. Personnel involved in the formulation or implementation of the research plan; 2. Patient participated in other clinical trails using other experimental drugs at the same time as the study; 3. The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ; 4. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 5. Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.
References
Publications (0)
Data not yet available