UMIN-CTR Clinical Trial

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
Email	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
Email	syo_suzuki@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054235