UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047555 |
|---|---|
| Receipt number | R000054235 |
| Scientific Title | Comparative Study of Physiological Uptake of FDG-PET in Colon and Colonoscopy for Colorectal Lesion Detection |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2022/04/22 12:06:17 |
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Basic information
Public title
Comparative Study of Physiological Uptake of FDG-PET in Colon and Colonoscopy for Colorectal Lesion Detection
Acronym
Detection rate of colorectal lesion for FDG-PET physiological uptake in colon
Scientific Title
Comparative Study of Physiological Uptake of FDG-PET in Colon and Colonoscopy for Colorectal Lesion Detection
Scientific Title:Acronym
Detection rate of colorectal lesion for FDG-PET physiological uptake in colon
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the colorectal cancer detection rate of physiological uptake of FDG-PET in the colon.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of colorectal cancer
Key secondary outcomes
Detection rate of adenomatous polyps
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent both FDG-PET and colonoscopy with an examination interval of 6 months or less
Key exclusion criteria
Cases in which abnormal accumulation was pointed out by FDG-PET
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
University of Miyazaki
Division name
Gastroenterology and Hepatology, Internal Medicine
Zip code
8891692
Address
5200 Kihara, Kiyotake Miyazaki
TEL
09858599797
syo_suzuki@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
University of Miyazaki
Division name
Gastroenterology and Hepatology, Internal Medicine
Zip code
8891692
Address
5200 Kihara, Kiyotake Miyazaki
TEL
0985859240
Homepage URL
syo_suzuki@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
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
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara, Kiyotake Miyazaki
Tel
0985851843
rinken@med.miyazaki-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
| 2022 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
184
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
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the frequency of colorectal tumors found at the physiological uptake site of FDG-PET.
Management information
Registered date
| 2022 | Year | 04 | Month | 22 | Day |
Last modified on
| 2022 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054235
