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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026303
Receipt No. R000030208
Scientific Title Homologous recombination Inquiry Through Ovarian Malignancy Investigations
Date of disclosure of the study information 2017/02/25
Last modified on 2019/08/29

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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
Obsterics 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
Email 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
Email yoshikou@med.niigata-u.ac.jp

Sponsor
Institute Japanese Gynecologic Oncology Group (JGOG)
Institute
Department

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
Email 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
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 No longer recruiting
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
2019 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030208

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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