Homologous Recombination Inquiry Through Ovarian Malignancy Investigations (HITOMI)

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status: Completed

Conditions: Primary Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03159572

JGOG3025

UMIN000026303 (Other Identifier)

Details and patient eligibility

About

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).

Full description

In this study, investigators plan to clarify the frequency of Homologous Recombination Deficiency (HRD) in Japanese patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).

And investigators will also investigate whether HRD-positive ovarian cancer patients show the clinical characteristics of highly platinum-sensitivity and good prognosis, comparing to HRD-negative ovarian cancer patients.

In addition, it is planned to investigate any association between Progression Free Survival (PFS) / Platinum-Sensitivity and germline mutation in Breast Cancer Susceptibility Gene (BRCA1/2 gene) in ovarian cancer patients who can provide the patients' gBRCA1/2 gene information for this study.

Enrollment: 996 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

996 participants in 1 patient group

Ovarian cancer group

Description:

Patients who are diagnosed with ovarian cancer and have a plan of surgery.