UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057252 |
|---|---|
| Receipt number | R000065444 |
| Scientific Title | An exploratory study on the accuracy of tissue diagnosis using transvaginal ultrasound and aspiration endometrial sampling equipment in screening for endometrial hyperplasia and uterine cancer in asymptomatic women undergoing physical and occupational health examinations. |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/10 17:19:44 |
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Basic information
Public title
An exploratory study on the accuracy of tissue diagnosis using transvaginal ultrasound and aspiration endometrial sampling equipment in screening for endometrial hyperplasia and uterine cancer in asymptomatic women undergoing physical and occupational health examinations.
Acronym
An exploratory study on the accuracy of tissue diagnosis
Scientific Title
An exploratory study on the accuracy of tissue diagnosis using transvaginal ultrasound and aspiration endometrial sampling equipment in screening for endometrial hyperplasia and uterine cancer in asymptomatic women undergoing physical and occupational health examinations.
Scientific Title:Acronym
An exploratory study on the accuracy of tissue diagnosis
Region
| Japan |
Condition
Condition
endometrial hyperplasia and uterine cancer
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether endometrial histology using a simple, low-pain aspiration endometrial sampling device can accurately diagnose endometrial hyperplasia (simple, complex, and atypical forms) and uterine cancer, and whether it is useful as a screening tool, in parallel with transvaginal ultrasound diagnosis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) The presence or absence of genital bleeding after the examination is counted.
(2) The frequency of progression from endometrial hyperplasia to uterine cancer is counted.
(3) Accuracy and superiority of examination and diagnosis
Key secondary outcomes
(1) The incidence of pain during examination of endometrial histology using a suction-type endometrial sampling device, the rate at which the device can be inserted, the frequency of bleeding, and the absence or presence of pain (degree I, II, and III) will be tabulated.
(2) Detection of lesions other than endometrial hyperplasia and uterine 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Those who are able to obtain consent by September 2034 after approval by the director of the facility
2) Females between the ages of 40 and 65 at the time of consent
3) Those who wish to have endometrial tissue diagnosis as a screening for uterine cancer
4) Patients who have undergone gynecological asymptomatic checkups and workplace gynecological checkups at Bene Asakusa Health Screening Center.
Key exclusion criteria
(1) Those who have refused to provide information
(2) Those who have symptoms such as irregular bleeding
(3) Pregnancy or the possibility of pregnancy
(4) Have an abnormality in blood coagulation
(5) Other patients who are deemed ineligible by the physician.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sasaki |
Organization
Medical Corporation Luce-kai
Division name
Bene Asakusa Health Checkup Clinic
Zip code
111-0033
Address
7F Asakusa Station Building EKIMISE, 1-4-1 Hanakawado, Taito-ku, Tokyo
TEL
03-6802-7910
hrssasaki0226@gmail.com
Public contact
Name of contact person
| 1st name | Natuki |
| Middle name | |
| Last name | Naobayashi |
Organization
Medical Corporation Luce-kai
Division name
Bene Asakusa Health Checkup Clinic
Zip code
111-0033
Address
7F Asakusa Station Building EKIMISE, 1-4-1 Hanakawado, Taito-ku, Tokyo
TEL
03-6802-7910
Homepage URL
hrssasaki0226@gmail.com
Sponsor or person
Institute
Medical Corporation Luce-kai
Institute
Department
Personal name
Hiroshi Sasaki
Funding Source
Organization
Medical Corporation Luce-kai
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Medical Corporation Luce-kai
Other related organizations
Co-sponsor
Tokyo Medical University, Hachioji Medical Center
Name of secondary funder(s)
Tokyo Medical University Hospital
IRB Contact (For public release)
Organization
Mirai Iryo Research Center Inc.
Address
1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
Secondary IDs
Secondary IDs
YES
Study ID_1
TGE02727-966
Org. issuing International ID_1
Mirai Iryo Research Center Inc.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団ルーチェ会（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) After approval by the Joint Ethical Review Committee and permission to conduct the study from the director of the institution, the procedures specified in
"11 Procedures for Obtaining Informed Consent, etc." will be followed.
(2) Endometrial tissue diagnosis will be performed using a suction-type endometrial sampling device.
(3) The following clinical information will be obtained from the medical records.
(i) Subject background (date of birth, age, sex, menopause, last menstrual period, number of pregnancies, deliveries, and miscarriages)
(ii) Medical history information and family history (presence or absence of colon cancer, breast cancer, uterine cancer, pancreatic cancer, bladder cancer, small intestine cancer, diabetes mellitus, etc.)
(iii) Date of examination
(iv) Whether or not endometrial hyperplasia and uterine cancer have occurred and whether or not the patient is asymptomatic
(v) Transvaginal ultrasound images at the time of gynecological examination
(vi) Histopathological findings and transvaginal ultrasound findings
(4) Presence or absence of pain during the examination, whether or not instruments can be inserted, and the amount of tissue sampled (large, medium, small)
(5) Ten-year follow-up is conducted, but asymptomatic checkups and gynecological checkups in the workplace are only available at the patient's request.
(6) Histopathological diagnosis will be made independently by two pathologists, and the concordance rate of the diagnosis of malignancy will be tested by the spermann's test.
Management information
Registered date
| 2025 | Year | 03 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065444
