UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032778 |
|---|---|
| Receipt number | R000037393 |
| Scientific Title | Clinical application of CT colonography |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2025/03/13 20:55:49 |
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Basic information
Public title
Clinical application of CT colonography
Acronym
CACTC
Scientific Title
Clinical application of CT colonography
Scientific Title:Acronym
CACTC
Region
| Japan |
Condition
Condition
Colorectal neoplasms
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of detectability and diagnostic performance for colorectal neoplasms of CT colonography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection rate for colorectal neoplasms and diagnositic accuracy for depth invasion of of CT colonography.
Key secondary outcomes
Percentage of change in treatment policy by CT colonography.
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
| 40 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Over 40 years old.Clinical information including image data of patients whose clinical CT colonography was performed within the period and informed consent was obtained in writing.
Key exclusion criteria
Those for whom the examination could not be completed for any reason, those blow 40 years old or who did not obtain consent in writing.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Fujimoto |
Organization
Gifu University
Division name
Department of Radiogoloy
Zip code
501-1194
Address
Yanagido 1-1,Gifu-shi,Gifu-ken
TEL
058-230-6437
keita.fujimoto.rad@gmail.com
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Fujimoto |
Organization
Gifu University
Division name
Department of Radiogoloy
Zip code
501-1194
Address
Yanagido 1-1,Gifu-shi,Gifu-ken
TEL
058-230-6437
Homepage URL
keita.fujimoto.rad@gmail.com
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
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
Gifu university Institutional Review Board
Address
Yanagido 1-1,Gifu-shi,Gifu-ken
Tel
058-230-6000
rinri@gifu-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
| 2020 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40019913/
Number of participants that the trial has enrolled
103
Results
This study analyzed 103 patients retrospectively using the CTC Reporting and Data System. Kaplan Meier analysis showed worse prognosis for E4 10.1 years vs E1 to E3 5.6 years ,p< 0.0001. Concordance between Past and Revised E was high 0.83. Prognosis differed between Revised E1 to E3 10.0 years and Revised E4 6.2 years ,p <0.0001.E4 strongly impacts prognosis while E2 and E3 have limited effects.
Results date posted
| 2025 | Year | 03 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 02 | Month | 28 | Day |
Baseline Characteristics
This study was approved by our institutional review board, and written informed consent was obtained from all participants prior to their inclusion. A total of 103 patients underwent clinical CTC examinations at Gifu University Hospital between May 2012 and February 2013. The cohort consisted of 59 males ,mean age, 67.3 years, range 40 to 85 years, and 44 females ,mean age, 66.9 years, range 42 to 88 years. Clinical indication-based CTC examinations, including follow-up for suspected colorectal abnormalities, were performed.
Participant flow
This study was approved by our institutional review board, and written informed consent was obtained from all participants prior to their inclusion. A total of 103 patients underwent clinical CTC examinations at Gifu University Hospital between May 2012 and February 2013. The cohort consisted of 59 males ,mean age, 67.3 year, range, 40 to 85 years, and 44 females ,mean age 66.9 year, range, 42 to 88 years. Clinical indication-based CTC examinations, including follow up for suspected colorectal abnormalities, were performed.
Adverse events
No obvious adverse events.
Outcome measures
The patients electronic medical records were reviewed from the time of examination until treatment, follow-up, or death. The list of patients who provided consent was pseudonymized, ensuring linkable anonymity, and their prognoses and clinical outcomes were tracked through electronic medical records from December 29, 2023, to January 29, 2024. Analyses were performed to assess the effect of identifying lesions categorized as Past E2 or higher on changes to the treatment plan. We evaluated additional diagnostic examinations triggered by extracolonic findings on CTC, such as CT, magnetic resonance imaging MRI, PET-CT, biopsy, and cytology. Electronic medical records were used to track all examinations to evaluate their influence on the treatment strategy. We determined if complete surgical resection, any form of chemotherapy, or radiation therapy resulted in at least one instance of partial response or complete response. The treatment outcomes, specifically the ability to achieve a clinical response on the basis of extracolonic lesion identification, were confirmed by reviewing the patients clinical records and treatment histories.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 10 | Day |
Other
Other related information
This study aimed to investigate the impact of colorectal tumors and their surrounding vascular characteristics on depth invasion and prognostic estimation.
Initially, the study planned to compare the latest reconstruction techniques available at the time, such as model based Iterative Reconstruction and iterative reconstruction, for image evaluation. However, by the time the image analysis experiments were ready to be conducted, significant advancements in AI based reconstruction techniques had emerged, leading to major technological shifts. Additionally, while the analysis confirmed significant differences in high contrast areas such as contrast enhanced blood vessels and parenchymal organs, consistent with previous reports, no significant differences were observed in the evaluation of low contrast areas in CT colonography, particularly in assessing the contrast between gas and soft tissues. Furthermore, in vascular analysis, due to data storage limitations, only the arterial phase could be retained, which restricted retrospective evaluations.
Meanwhile, a sub analysis was conducted in parallel to examine the prognostic impact of extracolonic findings, demonstrating that extracolonic lesions observed in CT colonography were associated with patient prognosis. However, prior to the publication of this sub analysis, a high volume center had already published a large scale study detailing the relationship between vascular invasion evaluation using CT colonography and patient prognosis. Given this, we concluded that the primary objective of this study had been fulfilled, and we decided to terminate the research.
Management information
Registered date
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037393
