Ovarian CancerHITOMINCT03159572
Homologous Recombination Inquiry Through Ovarian Malignancy Investigations
An observational study of Ovarian Cancer and Fallopian Tube Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
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). Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- How many people
- 996 participants
- Where
- 1 siteJapan
- Study dates
- 28 Mar 2017to 16 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult ovarian cancer patients who provided written informed consent including providing tumor tissue specimens before surgery.
Who may be able to join
- 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.
- Patients who are clinically diagnosed as having ovarian cancer and can provide written informed consent before the surgery.
- Patients who can provide tumor tissue specimens. (except ascites cytology and cell block specimens)
- Patients who are 20 years old and over at the enrollment.
- Patients with ECOG Performance status (PS): 0-2.
Who cannot join
- 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.
- 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.
- Any other cases that are inappropriate to enroll this study, judged by study principal investigator.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Niigata University Graduate School of Medical and Dental Sciences
Niigata, Niigata, 951-8510
About this study
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).
Read the 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.
- Keywords
- Ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer, Germline Breast Cancer Susceptibility Gene (BRCA1/2 gene), Homologous Recombination Deficiency (HRD)
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer group | Patients who are diagnosed with ovarian cancer and have a plan of surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 months
Secondary outcomes (2)
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.
Measured: 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)
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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start28 Mar 2017
- Primary completion16 Feb 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 996 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Obstetrics and Gynecology, School of Medicine, Niigata University, Japanese Gynecologic Oncology Group, Tohoku Medical Megabank Organization(ToMMo)
- Responsible party
- Sponsor
- Investigators
- Takayuki Enomoto, MD, Ph.D, Study chair, Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159572
- Sponsor's protocol ID
- JGOG3025
- Other IDs
- UMIN000026303
- Acronym
- HITOMI
- Status last verified
- Jan 2023
- First submitted
- 17 May 2017
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homologous Recombination Inquiry Through Ovarian Malignancy Investigations
- ClinicalTrials.gov ID
- NCT03159572
- Acronym / sponsor ID
- HITOMI / JGOG3025
- Keywords
- Ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer, Germline Breast Cancer Susceptibility Gene (BRCA1/2 gene), Homologous Recombination Deficiency (HRD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 996 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Department of Obstetrics and Gynecology, School of Medicine, Niigata University, Japanese Gynecologic Oncology Group, Tohoku Medical Megabank Organization(ToMMo)
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer group | – | –Patients who are diagnosed with ovarian cancer and have a plan of surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ovarian cancer patients who provided written informed consent including providing tumor tissue specimens before surgery.
Key inclusion criteria (5 listed)
- 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.
- Patients who are clinically diagnosed as having ovarian cancer and can provide written informed consent before the surgery.
- Patients who can provide tumor tissue specimens. (except ascites cytology and cell block specimens)
- Patients who are 20 years old and over at the enrollment.
- Patients with ECOG Performance status (PS): 0-2.
Key exclusion criteria (4 listed)
- 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.
- 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.
- Any other cases that are inappropriate to enroll this study, judged by study principal investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takayuki Enomoto, MD, Ph.D study chair
Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Fallopian Tube Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.