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Homologous recombination Inquiry Through Ovarian Malignancy Investigations

Homologous recombination Inquiry Through Ovarian Malignancy Investigations - HITOMI study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000026303
Enrollment
700
Registered
2017-02-25
Start date
2017-02-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)

Interventions

None listed

Sponsors

Japanese Gynecologic Oncology Group (JGOG)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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 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

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.

Design outcomes

Primary

MeasureTime frame
Frequency of HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)

Secondary

MeasureTime frame
Association between Progression Free Survival (PFS) / Response Rate and HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) Association between Progression Free Survival (PFS) / Response Rate and germline mutation in BRCA1/2 gene in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)

Countries

Japan

Contacts

Public ContactKosuke Yoshihara

Niigata University Graduate School of Medical and Dental Sciences Department of Obstetrics and Gynecology

yoshikou@med.niigata-u.ac.jp025-227-2320

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026