UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062673 |
|---|---|
| Receipt number | R000071387 |
| Scientific Title | Performance evaluation study of the POPLAR system, a diagnostic gene panel testing system for molecular subtype classification of endometrial cancer |
| Date of disclosure of the study information | 2026/08/26 |
| Last modified on | 2026/08/24 20:45:12 |
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Basic information
Public title
Performance study of the POPLAR system, a diagnostic system for molecular subtype classification of endometrial cancer
Acronym
POPLAR System Performance Study
Scientific Title
Performance evaluation study of the POPLAR system, a diagnostic gene panel testing system for molecular subtype classification of endometrial cancer
Scientific Title:Acronym
POPLAR System Performance Study
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to verify that the analytical performance of the POPLAR system, a diagnostic gene panel testing system for molecular subtype classification of endometrial cancer, is equivalent to that of existing testing methods used as reference methods.
The results of this study will be used for regulatory application of the POPLAR system as Software as a Medical Device (SaMD).
Basic objectives2
Others
Basic objectives -Others
Evaluation of the analytical performance of a diagnostic gene panel testing system
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity and specificity will be independently evaluated for the positive/negative results of the POPLAR system compared with the following four reference methods. Overall percent agreement, positive predictive value, and negative predictive value will also be evaluated as reference measures.
1. Presence or absence of 11 pathogenic POLE variants based on POLE mutation testing by Sanger sequencing
2. MSI-high or MSI-negative status based on dMMR assessment using MSI testing by PCR
3. dMMR or pMMR status based on dMMR assessment using MMR immunohistochemistry
4. Presence or absence of hotspot pathogenic variants in exons 4-9 based on TP53 mutation analysis by Sanger sequencing
Key secondary outcomes
1. The sensitivity, specificity, overall percent agreement, positive predictive value, and negative predictive value of p53 immunohistochemistry will be evaluated in comparison with TP53 mutation status determined by the POPLAR system and by Sanger sequencing.
2. Among cases with pathogenic POLE variants detected by the POPLAR system, the sensitivity, specificity, overall percent agreement, positive predictive value, and negative predictive value of MSI and TP53 results from the POPLAR system will be evaluated in comparison with the reference methods 2-4.
3. Among cases without pathogenic POLE variants detected by the POPLAR system, the sensitivity, specificity, overall percent agreement, positive predictive value, and negative predictive value of MSI and TP53 results from the POPLAR system will be evaluated in comparison with the reference methods 2-4.
4. The concordance rate will be evaluated between molecular subtype classification based on the POPLAR system algorithm, in the order of POLEmut > MSI-high > TP53 wild-type > TP53 mutant, and molecular subtype classification based on reference methods 1, 2, and 4.
5. The concordance rate between the reference MSI test and MMR immunohistochemistry will be evaluated. In addition, among specimens with concordant reference test results, namely MSI-high and dMMR or MSI-negative and pMMR, the concordance rate of MSI classification between the POPLAR system and each of the MSI test kit and MMR immunohistochemistry will be evaluated.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients aged 18 years or older at the time of consent
2. Patients pathologically diagnosed with endometrial cancer
3. Patients from whom a sufficient amount of tumor tissue required for the tests in this study can be provided
4. Patients who have provided written informed consent to participate in this study of their own free will, or patients for whom consent has been obtained for the use of samples and information in future medical research under a comprehensive consent system or equivalent framework at the participating institution
Key exclusion criteria
Patients judged by the principal investigator to be inappropriate for participation in this study
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Asano |
Organization
Hokkaido University
Division name
Department of Obstetrics, Hokkaido University Hospital
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5941
asano.hj@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Staff |
| Middle name | |
| Last name | POPLAR System Study Office |
Organization
Hokkaido University
Division name
Department of Obstetrics and Gynecology, Faculty of Medicine and Graduate School of Medicine
Zip code
060-8648
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5941
Homepage URL
POPLAR@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1.Collaborating research institution responsible for nucleic acid extraction, analysis using the POPLAR system, and validation by digital PCR and whole-exome sequencing
DNA Chip Research Inc.
Responsible person: Ryo Matoba
KDX Musashi-Kosugi Building 9F, 3-1200 Shinmaruko-higashi, Nakahara-ku, Kawasaki, Kanagawa 211-0004, Japan
TEL: +81-44-982-1330
2. Collaborating research institutions responsible for central pathology review
*Center for Development of Advanced Diagnostics, Hokkaido University Hospital: Kanako Hatanaka
*Department of Diagnostic Pathology, Teikyo University School of Medicine: Yuko Sasajima
*Department of Pathology, Okayama University Hospital: Hiroyuki Yanai
3. Collaborating research institutions responsible for case registration
*Hokkaido University Hospital
*Hokkaido Cancer Center
*National Cancer Center Hospital
Name of secondary funder(s)
DNA Chip Research Inc.
IRB Contact (For public release)
Organization
Research Ethics Review Committee for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-7636/+81-11-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）、北海道がんセンター（北海道）、国立がん研究センター中央病院（東京都）
Hokkaido University Hospital (Hokkaido), Hokkaido Cancer Center (Hokkaido), National Cancer Center Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 26 | 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
| 2025 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study using tumor tissue specimens from patients with endometrial cancer to evaluate the concordance between molecular subtype classification by the POPLAR system, a diagnostic gene panel testing system, and classification or test results obtained by existing reference methods. The factors to be evaluated are POLE mutation status, MSI status, TP53 mutation status, and molecular subtype classification determined by the POPLAR system. The outcomes are sensitivity, specificity, overall percent agreement, positive predictive value, negative predictive value, and the concordance rate of molecular subtype classification compared with the respective reference methods.
Management information
Registered date
| 2026 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071387
