UMIN-CTR Clinical Trial

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

Ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

YES

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

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)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japanese Gynecologic Oncology Group (JGOG)

Institute

Department

Personal name

Organization

Japanese Gynecologic Oncology Group

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

02

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Frequency of HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)

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