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Homologous Recombination Inquiry Through Ovarian Malignancy Investigations (HITOMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03159572
Recruitment Status : Completed
First Posted : May 18, 2017
Last Update Posted : January 20, 2023
Sponsor:
Collaborators:
Department of Obstetrics and Gynecology, School of Medicine, Niigata University
Japanese Gynecologic Oncology Group (JGOG)
Tohoku Medical Megabank Organization(ToMMo)
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Study Description
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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).

Condition or disease
Ovarian Cancer Fallopian Tube Cancer 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 Design
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Study Type : Observational
Actual Enrollment : 996 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Homologous Recombination Inquiry Through Ovarian Malignancy Investigations
Actual Study Start Date : March 28, 2017
Actual Primary Completion Date : February 16, 2022
Actual Study Completion Date : February 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.



Biospecimen Retention:   Samples With DNA
tumor tissue

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159572


Locations
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Japan
Niigata University Graduate School of Medical and Dental Sciences
Niigata city, Niigata Prefecture, Japan, 951-8510
Sponsors and Collaborators
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)
Investigators
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Study Chair: Takayuki Enomoto, MD, Ph.D Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences
More Information
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Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT03159572    
Other Study ID Numbers: JGOG3025
UMIN000026303 ( Other Identifier: UMIN-CTR )
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
Ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
Germline Breast Cancer Susceptibility Gene (BRCA1/2 gene)
Homologous Recombination Deficiency (HRD)
Additional relevant MeSH terms:
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Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
 Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases