Clinical trial · Observational
Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA
Japan CHARLOTTE: Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA
NCT03229122CI-TRIAL-00039000CHARLOTTEcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The multi-centered, cross-sectional investigations shall be conducted in this study with the objective of identifying the ownership ratio of gBRCAm on the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.
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
- Assessment of the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.
- timeFrame
- Baseline
- description
- To be evaluated based on laboratory test.
Secondary outcomes (2)
- measure
- Ownership ratio of gBRCAm when stratified according to the patients' demographics
- timeFrame
- Baseline
- description
- To be evaluated by laboratory test
- measure
- Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing
- timeFrame
- Baseline
- description
- To be evaluated by questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: For registration to this study, all of the following criteria should be satisfied: 1. The subject can attach the signature to the Informed Consent Form (ICF), besides having his/her intention to put the signature. 2. Female Japanese at more than 20 years of age 3. The newly diagnosed patients whose epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer is histologically confirmed as FIGO from the subject to obtain their utmost understandings. Limited to histopathological diagnosis based on resected tumor specimens (except the cytodiagnosis by ascites paracentesis). 4. The histopathological specimens can be submitted to the central pathological judgment. 5. Within 60 days after diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, the patient's written consent has been obtained. Exclusion Criteria: * The subjects who coincide any of the following exclusion criteria are designated to be ineligible: 1. In case of the subjects who are diagnosed to have acute or chronic physical or severe mental diseases except cancer, and about whom the attending responsible physician makes judgement to say that participation of these subjects would possibly increase the risks or would probably disturb the interpretation of the study results. 2. In case of the subjects whose registration for the study is judged by the attending responsible physician as inappropriate.
References
Publications (0)
Data not yet available
No reference posted for this study.