UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049594 |
|---|---|
| Receipt number | R000056480 |
| Scientific Title | Diagnostic accuracy of optical coherence tomography for patients with Ureteral cancer |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/02/02 09:57:01 |
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Basic information
Public title
Diagnostic accuracy of optical coherence tomography for patients with Ureteral cancer
Acronym
NOCTURN study
Scientific Title
Diagnostic accuracy of optical coherence tomography for patients with Ureteral cancer
Scientific Title:Acronym
NOCTURN study
Region
| Japan |
Condition
Condition
Ureteral tumor, Ureteral cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic accuracy of optical coherence tomography for tumor invasion to ureteral wall in patients with ureteral cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The diagnostic accuracy of optical coherence tomography in distinguishing Ta/Tis/T1 tumors and T2/T3 cancers.
Key secondary outcomes
1) The diagnostic accuracy of optical coherence tomography in determining Ta, Tis, T1, T2, and T3 ureteral cancers.
2) The diagnostic accuracy of optical coherence tomography in distinguishing Ta/Tis/T1/T2 tumors and T3 ureteral cancers.
3) The safety of optical coherence tomography test in patients with ureteral cancer (CTCAE ver 5.0).
4) Factors associated with misdiagnosis of optical coherence tomography in ureteral cancer T category.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Optical coherence tomography for ureteral tumor
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients suspected of having cTa to cT3 (computed tomography and/or magnetic resonance imaging)
2) ECOG-Performance Status: 0 to 2
3) Patients who are planning to undergo radical nephroureterectomy or partial ureterectomy for ureteral cancer.
4) Age, 20 to 90 years-old
5) Sufficient bone marrow function and organ functions within 60 days before the registration
Key exclusion criteria
1) Patients who cannot agree with enrollment of the study by his/her own intention
2) Inappropriate for the enrolment by the judgement of the physician because of psychosis or psychiatric symptoms
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Makito |
| Middle name | |
| Last name | Miyake |
Organization
Nara Medical University
Division name
Urology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051
makitomiyake@naramae-u.ac.jp
Public contact
Name of contact person
| 1st name | Makito |
| Middle name | |
| Last name | Miyake |
Organization
Nara Medical University
Division name
Urology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
https://www.naramed-u.ac.jp/~urol/about/theme.html
makitomiyake@naramae-u.ac.jp
Sponsor or person
Institute
Urology, Nara 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
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Nara Medical University Ethics Committee
Address
840 Shijo-cho, Kashihara, Nara, Japan
Tel
0744-22-3051
ino_rinri@naramed-u.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
奈良県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | 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 | 11 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2022 | Year | 11 | Month | 23 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056480
