UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061277 |
|---|---|
| Receipt number | R000070113 |
| Scientific Title | Evaluation of the Clinical Utility of AI-Generated Medical Literature Summaries: A Single-Blind Comparative Study with Conventional Secondary Sources |
| Date of disclosure of the study information | 2026/04/17 |
| Last modified on | 2026/04/16 12:00:36 |
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Basic information
Public title
Evaluation of the Clinical Utility of AI-Generated Medical Literature Summaries: A Single-Blind Comparative Study with Conventional Secondary Sources
Acronym
Evaluation of the Clinical Utility of AI-Generated Medical Literature Summaries: A Single-Blind Comparative Study with Conventional Secondary Sources
Scientific Title
Evaluation of the Clinical Utility of AI-Generated Medical Literature Summaries: A Single-Blind Comparative Study with Conventional Secondary Sources
Scientific Title:Acronym
Evaluation of the Clinical Utility of AI-Generated Medical Literature Summaries: A Single-Blind Comparative Study with Conventional Secondary Sources
Region
| Japan |
Condition
Condition
General medical conditions (Primary care topics)
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare and evaluate the clinical utility of summaries generated by the AI tool NotebookLM with those provided by UpToDate, the gold standard in clinical practice, among physicians in general medicine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of clinical acceptability as assessed by participants using a 5-point Likert scale.
Key secondary outcomes
Comparison of usability and perceived safety as assessed by participants using 5-point Likert scales, and comparison of the accuracy of source identification.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Group for evaluating Set A:Participants evaluate the utility of 20 Japanese-translated medical literature summaries:
1. Control (10 items): Original UpToDate summaries in text format.
2. Intervention (10 items): Summaries generated by NotebookLM using UpToDate's references as sources, following UpToDate's original structure and style.
Interventions/Control_2
Group for evaluating Set B:
Participants evaluate 20 Japanese-translated summaries where the assignment of "Intervention" and "Control" is the inverse of Set A for each clinical topic.
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
Male and Female
Key inclusion criteria
1. Physicians belonging to the Department of General Medicine, Dokkyo Medical University Hospital
2. Individuals who have provided voluntary written informed consent after receiving a thorough explanation of this study
Key exclusion criteria
Individuals who are judged by the principal investigator to be inappropriate for participation in this study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Arisa |
| Middle name | |
| Last name | Hayashi |
Organization
Dokkyo Medical University
Division name
Department of Diagnostic and Generalist Medicine
Zip code
321-0293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, Japan
TEL
0282-87-2498
arisa.hayashi211@gmail.com
Public contact
Name of contact person
| 1st name | Arisa |
| Middle name | |
| Last name | Hayashi |
Organization
Dokkyo Medical University
Division name
Department of Diagnostic and Generalist Medicine
Zip code
321-0293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, Japan
TEL
0282-87-2498
Homepage URL
arisa.hayashi211@gmail.com
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Dokkyo Medical University
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, Japan
Tel
0282-87-2275
r-kenkyu@dokkyomed.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
| 2026 | Year | 04 | Month | 17 | 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 | 10 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 16 | Day |
Last modified on
| 2026 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070113
