Clinical trial NCT03159572: Homologous Recombination Inquiry Through Ovarian Malignancy Investigations
Official title: Homologous Recombination Inquiry Through Ovarian Malignancy Investigations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Keywords: Ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
Germline Breast Cancer Susceptibility Gene (BRCA1/2 gene)
Homologous Recombination Deficiency (HRD)
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Department of Obstetrics and Gynecology, School of Medicine, Niigata University
name: Japanese Gynecologic Oncology Group
name: Tohoku Medical Megabank Organization(ToMMo)
First posted: 2017-05-18
Enrollment: 996
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ovarian cancer patients who provided written informed consent including providing tumor tissue specimens before surgery.

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.

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.

Primary outcomes:
measure: Frequency of HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
timeFrame: 17 months
Secondary outcomes:
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
measure: 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)
timeFrame: 48 months
Other outcomes:
Locations:
city: Niigata city
country: Japan
facility: Niigata University Graduate School of Medical and Dental Sciences
state: Niigata Prefecture
Study officials:
affiliation: Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences
name: Takayuki Enomoto, MD, Ph.D
role: STUDY_CHAIR
References: