Homologous Recombination Inquiry Through Ovarian Malignancy Investigations

NCT ID: NCT03159572

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 996 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2022-02-16

Brief Summary

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).

Detailed 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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Ovarian cancer group

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

No interventions assigned to this group

Eligibility 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 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Department of Obstetrics and Gynecology, School of Medicine, Niigata University

UNKNOWN

Sponsor Role: collaborator

Japanese Gynecologic Oncology Group

OTHER

Sponsor Role: collaborator

Tohoku Medical Megabank Organization(ToMMo)

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takayuki Enomoto, MD, Ph.D

Role: STUDY_CHAIR

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

Locations

Niigata University Graduate School of Medical and Dental Sciences

Niigata, Niigata, Japan

Countries

Japan

Other Identifiers

UMIN000026303

Identifier Type: OTHER

Identifier Source: secondary_id

JGOG3025

Identifier Type: -

Identifier Source: org_study_id