UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026303 |
|---|---|
| Receipt number | R000030208 |
| Scientific Title | Homologous recombination Inquiry Through Ovarian Malignancy Investigations |
| Date of disclosure of the study information | 2017/02/25 |
| Last modified on | 2023/03/02 16:14:35 |
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Basic information
Public title
Homologous recombination Inquiry Through Ovarian Malignancy Investigations
Acronym
HITOMI study
Scientific Title
Homologous recombination Inquiry Through Ovarian Malignancy Investigations
Scientific Title:Acronym
HITOMI study
Region
| Japan |
Condition
Condition
Ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
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)
Basic objectives2
Others
Basic objectives -Others
Exploratory research of Homologous Recombination Deficiency (HRD)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
Key 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)
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)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key 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 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
Key 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.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Enomoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Obstetrics and Gynecology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan
TEL
025-227-2320
enomoto@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Yoshihara |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Obstetrics and Gynecology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan
TEL
025-227-2320
Homepage URL
yoshikou@med.niigata-u.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group (JGOG)
Institute
Department
Personal name
Funding Source
Organization
Japanese Gynecologic Oncology Group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Gynecologic Oncology Group
Address
4F, Komatsu Building, 6-22, Kagurazaka, Shinjuku-ku, Tokyo, 162-0825, Japan
Tel
03-5206-1982
yoshikou@med.niigata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
711
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Frequency of HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
Management information
Registered date
| 2017 | Year | 02 | Month | 25 | Day |
Last modified on
| 2023 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030208
