UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050039 |
|---|---|
| Receipt number | R000057004 |
| Scientific Title | Development of the AI system for early detection of ovarian cancer using cancer specific glycoprotein markers and peaks from comprehensive serum glycopeptide spectra analysis (CSGSA) |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2024/09/09 14:51:42 |
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Basic information
Public title
Development of the AI system for early detection of ovarian cancer using cancer specific glycoprotein markers and peaks from comprehensive serum glycopeptide spectra analysis (CSGSA)
Acronym
Development of the AI system for early detection of ovarian cancer
Scientific Title
Development of the AI system for early detection of ovarian cancer using cancer specific glycoprotein markers and peaks from comprehensive serum glycopeptide spectra analysis (CSGSA)
Scientific Title:Acronym
Development of the AI system for early detection of ovarian cancer
Region
| Japan |
Condition
Condition
Ovarian Cancer, Endometrioma, Healthy women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of the AI system for early detection of ovarian cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC, sensitivity, Specificity, PPV, NPV by AI system for early detection of ovarian cancer
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Examinee for health check up
Patient with ovarian cancer
Patinets with endomtrioma
Key exclusion criteria
Examinee judged inappropriate for this trial by researcher in charge
Target sample size
3450
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Imanishi |
Organization
Tadashi Imanishi
Tokai University, School of Medicine
Division name
Genome Diversity Research Center
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagaw, Japan 259-1193
TEL
0463-93-1121
mmikami@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Mikio |
| Middle name | |
| Last name | Mikami |
Organization
Shonan University of Medical Science/Chigasaki Central Hospital
Division name
Department of Obstetrics and GYnecology
Zip code
253-0041
Address
2-2-3Chigasaki, Chigasaki, Kanagawa
TEL
080-4776-5776
Homepage URL
mmikami@tokai.ac.jp
Sponsor or person
Institute
Tokai University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara, Kanagaw, Japan 259-1193
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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
| 2023 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
EXaminees for healthe check up who are diagnosed Rank C (Amongpexaminees with Rank C, ovarian cancer can be detected 3% currently), should be course observed at medical office continously whether they have ovarian tumors not.
As of January 4, 2024, a total of 972 patients have been enrolled in the study.
Management information
Registered date
| 2023 | Year | 01 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057004
