UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006665 |
|---|---|
| Receipt number | 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 16:42:12 |
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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
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/
jichirad-ctc@hotmail.co.jp
Sponsor or person
Institute
Department od Medical Division of Radiology, Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007815
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| Registered date | File name |
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| Registered date | File name |
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