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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002755
Receipt No. R000001474
Scientific Title Detectability of 3D-CT for laterally spreading tumor of the colorectum
Date of disclosure of the study information 2009/11/30
Last modified on 2019/06/13

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Basic information
Public title Detectability of 3D-CT for laterally spreading tumor of the colorectum
Acronym Detectability of 3D-CT for LST
Scientific Title Detectability of 3D-CT for laterally spreading tumor of the colorectum
Scientific Title:Acronym Detectability of 3D-CT for LST
Region
Japan

Condition
Condition Laterally spreading tumor of the colorectum
Classification by specialty
Gastroenterology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify detectability of 3D-CT for the laterally spreading tumor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Detection of laterally spreading tumor by 3D-CT
Key secondary outcomes Morphology of the laterally spreading tumor on 3D-CT

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 Perform 3D-CT examination after colonoscopy
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

Not applicable
Gender Male and Female
Key inclusion criteria The patients who have laterally spreadint tumors measuring 2 cm or greater on colonoscopy
Key exclusion criteria Inflammatory bowel disease patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kazutomo
Middle name
Last name Togashi
Organization Jichi Medical University
Division name Endoscopy
Zip code 329-0434
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7371
Email k-utano@nifty.com

Public contact
Name of contact person
1st name Utano
Middle name
Last name Kenichi
Organization Jichi Medical University
Division name Radiology
Zip code 329-0498
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-44-2100
Homepage URL
Email k-utano@nifty.com

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Jichi Medical University
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 Jichi Medical University
Address 3311-1 Ykashiji, Shimotsuke, Tochigi
Tel 0285442111
Email ktogashi@jichi.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 自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 30 Day

Related information
URL releasing protocol PubMed PMID: 25516670
Publication of results Published

Result
URL related to results and publications PubMed PMID: 25516670
Number of participants that the trial has enrolled 47
Results
Histology included adenomas in 19, mucosal cancers in 19 and T1 cancers in 9. Twenty-eight (60%) LSTs were correctly identified by CTC. Detection rate for the granular type was significantly higher than that for the non-granular type (71% vs 31%, P = 0.013). Detection rate of adenomas was significantly lower than mucosal cancers (32% vs 79%, P = 0.008) and T1 cancers (32% vs 78%, P = 0.042). 
Results date posted
2019 Year 06 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with colorectal neoplasms
Participant flow
No drop-outs
Adverse events
None
Outcome measures
Diagnostic performance
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 02 Month 14 Day
Date of IRB
2008 Year 03 Month 14 Day
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information Main results have been submitted to World Journal of Gastroenterology, and were accepted for publication on June 2, 2014.

Management information
Registered date
2009 Year 11 Month 11 Day
Last modified on
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001474

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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