UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049518 |
|---|---|
| Receipt number | R000056391 |
| Scientific Title | Non-inferiority study of preoperative biopsy versus endoscopic diagnosis of superficial duodenal epithelial tumours. |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/11/16 00:08:11 |
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Basic information
Public title
Non-inferiority study of preoperative biopsy versus endoscopic diagnosis of superficial duodenal epithelial tumours.
Acronym
Non-inferiority study of preoperative biopsy versus endoscopic diagnosis of superficial duodenal epithelial tumours.
Scientific Title
Non-inferiority study of preoperative biopsy versus endoscopic diagnosis of superficial duodenal epithelial tumours.
Scientific Title:Acronym
Non-inferiority study of preoperative biopsy versus endoscopic diagnosis of superficial duodenal epithelial tumours.
Region
| Japan |
Condition
Condition
Superficial duodenal epithelial tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Demonstrate that the correct diagnosis rate of endoscopic diagnosis is non-inferior to that of biopsy diagnosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
accuracy rate
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
| 89 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases with epithelial tumours in the duodenum, where endoscopic treatment is planned for lesions suspected to be adenomas or carcinomas.
Key exclusion criteria
Familial adenomatous polyposis
Critical organ failure
Cases deemed inadmissible for entry by the attending physician
Cases where consent for treatment and research cannot be obtained
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hirose |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya,
TEL
052-744-2111
taka-h@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hirose |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya,
TEL
052-744-2111
Homepage URL
taka-h@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya,
Tel
0527412111
taka-h@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient information, blood test results, endoscopic findings, endoscopic treatment modalities, biopsy pathology results, excisional pathology results, immunostaining results, mucus trait assessment, etc.
Management information
Registered date
| 2022 | Year | 11 | Month | 16 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056391
