Homologous Recombination Inquiry Through Ovarian Malignancy Investigations

Ovarian Cancer Clinical Trial

— HITOMI  

Official title:

Homologous Recombination Inquiry Through Ovarian Malignancy Investigations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159572
• Other study ID #: JGOG3025
• Secondary ID: UMIN000026303
• Status: Completed
• Start date: March 28, 2017
• Est. completion date: February 16, 2022

Study information

• Verified date: January 2023
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 996
• Est. completion date: February 16, 2022
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Cancer

Locations

Country	Name	City	State
Japan	Niigata University Graduate School of Medical and Dental Sciences	Niigata city	Niigata Prefecture

Sponsors (4)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Department of Obstetrics and Gynecology, School of Medicine, Niigata University, Japanese Gynecologic Oncology Group (JGOG), Tohoku Medical Megabank Organization(ToMMo)

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)	When all tumor samples are stored at ToMMo after the term of registration, DNA are extracted from frozen tumor tissue. These extracted tumor DNA, after confirmed at inspection body that it has constant qualities, are examined for HRD by DNA target sequencing.	17 months
Secondary	Association between Progression Free Survival (PFS) / Response Rate and HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)	PFS is calculated from registration date to the date diagnosed as progression or the date of death from any cause, whichever comes earlier. Response rate(RR) is determined the rate of patients who are evaluated of best overall response as CR(complete response) or PR(partial response) from those with measurable disease (based on Guidelines to Evaluate the Response to Treatment in Solid Tumors, RESIST).; Association between PFS/RR and HRD which is clarified as primary outcome is assessed.	48 months
Secondary	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)	PFS is calculated from registration date diagnosed as having progression or the date of death from any cause, whichever comes earlier. Response rate(RR) is determined the rate of patients who are evaluated of best overall response as CR(complete response) or PR(partial response) from those with measurable disease (based on Guidelines to Evaluate the Response to Treatment in Solid Tumors, RESIST).; Association between PFS/RR and gBRCA1/2 gene information from patients who can provide their gBCRA1/2 gene information with their informed consent, is evaluated.	48 months