UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061233 |
|---|---|
| Receipt number | R000070072 |
| Scientific Title | beta-trace protein concentrations in cerebrospinal fluid and epidural aspirates: a prospective observational study |
| Date of disclosure of the study information | 2026/04/12 |
| Last modified on | 2026/04/12 02:20:37 |
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Basic information
Public title
beta-trace protein concentrations in cerebrospinal fluid and epidural aspirates: a prospective observational study
Acronym
beta-trace protein concentrations in cerebrospinal fluid and epidural aspirates: a prospective observational study
Scientific Title
beta-trace protein concentrations in cerebrospinal fluid and epidural aspirates: a prospective observational study
Scientific Title:Acronym
beta-trace protein concentrations in cerebrospinal fluid and epidural aspirates: a prospective observational study
Region
| Japan |
Condition
Condition
Differentiation of cerebrospinal fluid and epidural fluid
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic utility of beta-trace protein (BTP) for distinguishing cerebrospinal fluid from epidural fluid.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic performance of beta-trace protein (BTP) concentration in differentiating cerebrospinal fluid (CSF) from epidural fluid, assessed by receiver operating characteristic (ROC) curve analysis (area under the curve, sensitivity, and specificity).
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 to 75 years with American Society of Anesthesiologists physical status I or II who were scheduled to undergo elective surgery under general anesthesia with epidural analgesia or spinal anesthesia, and from whom epidural aspirates or cerebrospinal fluid samples could be collected for analysis.
Key exclusion criteria
Patients who did not meet the inclusion criteria, those in whom epidural aspirates or cerebrospinal fluid samples could not be obtained, and those judged by the investigators to be inappropriate for participation.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Misuzu |
| Middle name | |
| Last name | Hayashi |
Organization
University of the Ryukyus Hospital
Division name
Department of Anesthesiology
Zip code
901-2725
Address
1076 Kiyuna, Ginowan City, Okinawa, Japan
TEL
098-894-1301
hayashi_fggz@cs.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Misuzu |
| Middle name | |
| Last name | Hayashi |
Organization
University of the Ryukyus Hospital
Division name
Department of Anesthesiology
Zip code
02478
Address
1076 Kiyuna, Ginowan City, Okinawa, Japan
TEL
098-894-1301
Homepage URL
hayashi_fggz@cs.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus Hospital
Institute
Department
Personal name
Funding Source
Organization
This study received no external funding.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of the University of the Ryukyus for Medical and Health Research Involving Human Subjects
Address
1 Senbaru, Nishihara-cho, Nakagami-gun, Okinawa, Japan
Tel
098-894-1365
krinken@acs.u-ryukyu.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 | 12 | Day |
Related information
URL releasing protocol
N/A (protocol not publicly available)
Publication of results
Unpublished
Result
URL related to results and publications
Not available (results not yet publicly available)
Number of participants that the trial has enrolled
80
Results
A total of 80 participants were enrolled. beta-trace protein (BTP) concentrations were higher in cerebrospinal fluid (CSF) than in epidural samples, demonstrating clear discrimination between the groups.
Receiver operating characteristic (ROC) analysis indicated that BTP showed superior diagnostic performance compared with glucose and total protein.
Results date posted
| 2026 | Year | 04 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included adult patients aged 20 to 75 years with American Society of Anesthesiologists physical status I or II. Participants were divided into two groups: patients undergoing epidural catheter placement and those undergoing spinal anesthesia. No significant differences in baseline demographic characteristics were observed between groups.
Participant flow
A total of 80 participants were enrolled in the study. Seventy-four participants were assigned to the epidural group, and 6 participants were assigned to the cerebrospinal fluid (CSF) group.
Epidural aspirates were successfully obtained from 20 participants in the epidural group. All participants in the CSF group provided cerebrospinal fluid samples for analysis.
All collected samples were included in the final analysis.
Adverse events
No adverse events related to the study procedures were observed.
Outcome measures
The diagnostic accuracy of beta-trace protein (BTP) concentration for distinguishing cerebrospinal fluid (CSF) from epidural aspirates, assessed using receiver operating characteristic (ROC) curve analysis.
Diagnostic performance of glucose and total protein concentrations for distinguishing CSF from epidural samples
Determination of optimal cutoff values for each biomarker
Correlation between time from epidural drug administration to sampling and biomarker concentrations in epidural aspirates
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a prospective observational study. No interventions were assigned to participants. Epidural aspirates and cerebrospinal fluid (CSF) samples were collected as part of routine clinical procedures, and biomarker concentrations, including beta-trace protein (BTP), glucose, and total protein, were measured and compared between groups. Diagnostic performance was evaluated using receiver operating characteristic (ROC) curve analysis.
Management information
Registered date
| 2026 | Year | 04 | Month | 12 | Day |
Last modified on
| 2026 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070072
