UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014772 |
|---|---|
| Receipt number | R000016867 |
| Scientific Title | Detectability of >=2 cm of Flat-shaped Laterally Spreading Tumor using Colon Capsule Endoscopy and CT Colonography |
| Date of disclosure of the study information | 2014/08/06 |
| Last modified on | 2020/08/10 07:36:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Detectability of >=2 cm of Flat-shaped Laterally Spreading Tumor using Colon Capsule Endoscopy and CT Colonography
Acronym
Detectability of LST using CCE and CTC
Scientific Title
Detectability of >=2 cm of Flat-shaped Laterally Spreading Tumor using Colon Capsule Endoscopy and CT Colonography
Scientific Title:Acronym
Detectability of LST using CCE and CTC
Region
| Japan |
Condition
Condition
colorectal flat-shaped neoplasms measuring 2 cm or greater
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify detectability of >=2 cm of flat-shaped colorectal neoplasms using colon capsule endoscopy and CT colonography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
detection rates by modality
Key secondary outcomes
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
colon capsule endoscopy
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 referred for endoscopic submucosal dissection of colorectal flat-shaped neoplasms measuring 2 cm or greater
Key exclusion criteria
unable to know final histology
resected lesion measuring less than 15mm
cancer invading proper muscle layer
colon capsule did not reach to the lesion
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazutomo |
| Middle name | |
| Last name | Togashi |
Organization
Aizu Medical Center Fukushima Medical University
Division name
Dept. of Coloproctology
Zip code
969-3492
Address
Aizuwakamatsu-city
TEL
0242-27-2100
togashik@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Jinko |
| Middle name | |
| Last name | Kobayashi |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Corporate Planning Office
Zip code
969-3492
Address
Aizuwakamatsu-city
TEL
0242-27-2100
Homepage URL
jinko-kb@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hkarigaoka, Fukushima-city, Fukushima
Tel
024-547-1825
rs@fmu.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
福島県立医科大学会津医療センター（福島県）
小樽掖済会病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
DOI: 10.1159/000501609
Publication of results
Published
Result
URL related to results and publications
DOI: 10.1159/000501609
Number of participants that the trial has enrolled
27
Results
Per patient sensitivities were 0.89 (24/27) by CCE and 0.70 (19/27) by CTC (P=0.0253, McNemar), and per lesion sensitivities were 0.87 (26/30) and 0.67 (20/30), respectively (P=0.0143).
Results date posted
| 2020 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with LST
Participant flow
DOI: 10.1159/000501609
Adverse events
None
Outcome measures
Detectability of LST
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Oral presentation at DDW 2016
Management information
Registered date
| 2014 | Year | 08 | Month | 06 | Day |
Last modified on
| 2020 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016867
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/11/17 | 101 研究計画書（別紙様式１）大腸カプセル.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/11/17 | FixedData.xlsx |
