Clinical trial · Observational
Homologous Recombination Inquiry Through Ovarian Malignancy Investigations
NCT03159572CI-TRIAL-00082854HITOMIcompletedClinicalTrials.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)
To investigate the frequency and clinical significance of Homologous Recombination Deficiency (HRD) in Japanese patients with ovarian cancer (including Fallopian tube cancer and primary peritoneal cancer).
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 |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Ovarian cancer group
- description
- Patients who are diagnosed with ovarian cancer and have a plan of surgery.
Primary outcomes (1)
- measure
- Frequency of HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
- timeFrame
- 17 months
- description
- When all tumor samples are stored at ToMMo after the term of registration, DNA are extracted from frozen tumor tissue. These extracted tumor DNA, after confirmed at inspection body that it has constant qualities, are examined for HRD by DNA target sequencing.
Secondary outcomes (2)
- measure
- Association between Progression Free Survival (PFS) / Response Rate and HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
- timeFrame
- 48 months
- description
- PFS is calculated from registration date to the date diagnosed as progression or the date of death from any cause, whichever comes earlier. Response rate(RR) is determined the rate of patients who are evaluated of best overall response as CR(complete response) or PR(partial response) from those with measurable disease (based on Guidelines to Evaluate the Response to Treatment in Solid Tumors, RESIST). Association between PFS/RR and HRD which is clarified as primary outcome is assessed.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who can approve informed consent and sign it. Patients who show their will to participate in this study and can sign the informed consent forms by themselves. 2. Patients who are clinically diagnosed as having ovarian cancer and can provide written informed consent before the surgery. 3. Patients who can provide tumor tissue specimens. (except ascites cytology and cell block specimens) 4. Patients who are 20 years old and over at the enrollment. 5. Patients with ECOG Performance status (PS): 0-2. Exclusion Criteria: 1. Patients with active concomitant malignancy\* except breast cancer. \*Includes synchronous multiple cancer and metachronous multiple cancer with less than 5 years of disease free survival. However, excludes skin basal cell carcinoma, skin squamous cell carcinoma, and any other curable lesions with local therapy such as carcinoma in situ or intramucosal carcinoma. 2. Patients who are diagnosed as any other acute/chronic, physically/mentally severe diseases and judged by the primary physician as inappropriate to enroll this study because of safety reasons or any influence to study outcomes. 3. Any other cases that are inappropriate to enroll this study, judged by study principal investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.