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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014772
Receipt No. 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 2017/11/17

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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
Middle name
Last name Kazutomo Togashi
Organization Aizu Medical Center Fukushima Medical University
Division name Dept. of Coloproctology
Zip code
Address Aizuwakamatsu-city
TEL 0242-27-2100
Email togashik@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jinko Kobayashi
Organization Aizu Medical Center, Fukushima Medical University
Division name Corporate Planning Office
Zip code
Address Aizuwakamatsu-city
TEL 0242-27-2100
Homepage URL
Email jinko-kb@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

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
Address
Tel
Email

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
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Three lesions with a protruding configuration or advanced cancer were excluded, leaving a total of 30 lesions (T1 cancer: 3, Tis cancer: 7, adenoma 14, sessile serrated adenoma/polyp: 6) in 27 patients for evaluation. The capsule excretion rate within eight hours was 85% (23/27), and all capsules went beyond the target lesions. 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
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 No longer recruiting
Date of protocol fixation
2014 Year 05 Month 14 Day
Date of IRB
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
2017 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.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


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