Clinical trial · Observational
China Ovarian Cancer BRCA Testing Study
China Local BRCA Testing and Exploration of Ovarian Cancer Treatment Outcomes of Different BRCA Status in Newly Diagnosed Epithelial Ovarian Cancer Patients
NCT03203993CI-TRIAL-00047666CRONUSterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Failure to obtain HGR approval.
Summary
Brief summary (as posted)
This is a prospective, multi-center, observational study, the primary objective is to evaluate the prevalence of gBRCA/sBRCAm in newly diagnosed ovarian cancer patients and explore ovarian cancer treatment outcomes of different BRCAm status
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations
- timeFrame
- 1 year
- description
- To evaluate the prevalence of gBRCA mutation and sBRCA mutation in newly diagnosed ovarian cancer patients
Secondary outcomes (2)
- measure
- Progression-free survival (PFS)
- timeFrame
- 18 months
- description
- To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of PFS
- measure
- Overall survival (OS)
- timeFrame
- up to 5 years
- description
- To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of OS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * Be able and willing to sign the informed consent form (ICF) * Female aged 18 years or over * Have histologically confirmed new diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made by one or more of the following: * standard staging laparotomy including bilateral salpingo-oophorectomy, omentectomy, and lymph node sampling and debulkingand/or * surgical resection and radiographic evidence consistent with Stage III or IV ovarian cancer * biopsy with radiographic evidence consistent with Stage III or IV ovarian cancer * Have availability of paraffin-embedded archivedtumor tissue block (preferred) or,if a block is not possible, a minimum of twenty 5-μm unstained sections. (Tumor tissue should be archived at diagnosis. 10 slides is utilized for sBRCA testing after the enrolment. Another 10 slides is utilized for exploratory evaluation of HRR gene mutations in a retrospective way.) * Have a diagnosis that is within 60 days of informed consent Exclusion Criteria: * Have a diagnosis of additional concurrent malignancies or previous diagnosis of another malignancy with current evidence of residual disease * Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study * Be currently participating in any other clinical trial for first-line treatment of ovarian cancer * Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study
References
Publications (0)
Data not yet available
No reference posted for this study.