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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006665
Receipt No. R000007815
Scientific Title Diagnostic accuracy of low dose polyethylene glycol (PEG) based fecal tagging computed tomography colonography (CTC) for the detection of colorectal neoplasia in patients with positive fecal immunochemical test
Date of disclosure of the study information 2011/11/04
Last modified on 2016/11/07

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Basic information
Public title Diagnostic accuracy of low dose polyethylene glycol (PEG) based fecal tagging computed tomography colonography (CTC) for the detection of colorectal neoplasia in patients with positive fecal immunochemical test
Acronym Diagnostic accuracy of low dose bowel preparation based fecal tagging CT colonography for the detection of colorectal neoplasia
Scientific Title Diagnostic accuracy of low dose polyethylene glycol (PEG) based fecal tagging computed tomography colonography (CTC) for the detection of colorectal neoplasia in patients with positive fecal immunochemical test
Scientific Title:Acronym Diagnostic accuracy of low dose bowel preparation based fecal tagging CT colonography for the detection of colorectal neoplasia
Region
Japan

Condition
Condition colorectal cancer, colorectal polyp
Classification by specialty
Gastroenterology Radiology Laboratory medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To address the accuracy of CT colonography (CTC) in detecting colorectal polyps and cancers in subjects with positive fecal immunochemical test, using optical colonoscopy as the reference standard.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Low dose polyethylene glycol (PEG) based fecal tagging CTC vs. optical colonoscopy. Detection performance and accuracy of colorectal polyps (at least 6 mm in diameter) and colorectal cancer.
Key secondary outcomes Comparative adherence of patients to CTC and optical colonoscopy.
Frequency and nature of any adverse events.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 CTC and optical 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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) fecal immunochemical test positive.
2) Major functions of organs of the subjects are in a good condition.
3) Aged 40 years or older.
4) Signed informed consent forms are obtained by the patients.
Key exclusion criteria 1) Known colorectal polyps or cancers at any site at the time of enrollment.
2) Patients with inflammatory bowel disease.
3) Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
4) Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.
5) Previous colorectal surgery.
6) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
7) Evidence of an increased risk in carrying out bowel preparation or CTC exams.
8) Possibility of pregnancy.
9) Optical colonoscopy or barium enema carried out within the last 3 years.
10) Patients with psychological conditions that contraindicate colonoscopy or make them irrelevant to participate in the trial.
11) Claustrophobia.
12) Iodine hypersensitivity.
13) Severe thyroid disease.
14) Severe deafness.
15) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideharu Sugimoto MD, Kenichi Utano, MD, Koichi Nagata MD, Tetsuro Honda MD
Organization Jichi Medical University
Division name Department of Medical Division of Radiology and Gastroenterology
Zip code
Address 3311-1, Yakushiji, Shimono, Tochigi, 329-0498, Japan
TEL 0285-58-7362
Email nagata7@aol.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Utano, MD
Organization Jichi Medical University
Division name Department of Medical Division of Radiology
Zip code
Address 3311-1, Yakushiji, Shimono, Tochigi, 329-0498, Japan
TEL 0285-58-7362
Homepage URL http://www.jichi.ac.jp/radiol/
Email jichirad-ctc@hotmail.co.jp

Sponsor
Institute Department od Medical Division of Radiology, Jichi Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor 1. Otaru Kyokai Hospital
2. Hokkaido Gastroenterology Hospital
3. Tonan Hospital
4. Kameda Medical Center Makuhari
5. Kameda General Hospital
6. Matsuda Hospital
7. Kamigoto Hospital
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 北海道社会事業協会小樽病院(北海道)、北海道消化器科病院(北海道)、KKR札幌医療センター 斗南病院(北海道)、自治医科大学附属病院(栃木県)、亀田メディカルセンター幕張(千葉県)、亀田総合病院(千葉県)、松田病院(静岡県)、長崎県 上五島病院(長崎県)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://pubs.rsna.org/doi/full/10.1148/radiol.2016160320
Number of participants that the trial has enrolled
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
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 11 Month 03 Day
Last modified on
2016 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007815

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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