Homologous Recombination Inquiry Through Ovarian Malignancy Investigations (HITOMI)

November 18, 2024 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
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).

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

996

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Niigata Prefecture
      • Niigata city, Niigata Prefecture, Japan, 951-8510
        • Niigata University Graduate School of Medical and Dental Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult ovarian cancer patients who provided written informed consent including providing tumor tissue specimens before surgery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Ovarian cancer group
Patients who are diagnosed with ovarian cancer and have a plan of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
Time Frame: 17 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between Progression Free Survival (PFS) / Response Rate and HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
Time Frame: 48 months

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
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)
Time Frame: 48 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Japanese Gynecologic Oncology Group (JGOG)
Department of Obstetrics and Gynecology, School of Medicine, Niigata University
Tohoku Medical Megabank Organization(ToMMo)

Investigators

  • Study Chair: Takayuki Enomoto, MD, Ph.D, Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2017

Primary Completion (Actual)

February 16, 2022

Study Completion (Actual)

February 16, 2022

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JGOG3025
  • UMIN000026303 (Other Identifier: UMIN-CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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