Brief Title
Homologous Recombination Inquiry Through Ovarian Malignancy Investigations
Official Title
Homologous Recombination Inquiry Through Ovarian Malignancy Investigations
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.
Study Type
Observational
Primary Outcome
Frequency of HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
Secondary Outcome
Association between Progression Free Survival (PFS) / Response Rate and HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
Condition
Ovarian Cancer
Study Arms / Comparison Groups
Ovarian cancer group
Description: Patients who are diagnosed with ovarian cancer and have a plan of surgery.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
996
Start Date
March 28, 2017
Completion Date
September 2021
Primary Completion Date
September 2021
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.
Gender
Female
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Takayuki Enomoto, MD, Ph.D, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT03159572
Organization ID
JGOG3025
Secondary IDs
UMIN000026303
Responsible Party
Sponsor
Study Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Department of Obstetrics and Gynecology, School of Medicine, Niigata University
Study Sponsor
Takayuki Enomoto, MD, Ph.D, Study Chair, Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences
Verification Date
June 2020