UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009456 |
|---|---|
| Receipt number | R000011104 |
| Scientific Title | Patient preferences for colonoscopy, CT colonography, and bowel preparation: prospective comparative study in patients with fecal immunochemical test positive. |
| Date of disclosure of the study information | 2012/12/04 |
| Last modified on | 2015/08/03 20:22:57 |
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Basic information
Public title
Patient preferences for colonoscopy, CT colonography, and bowel preparation: prospective comparative study in patients with fecal immunochemical test positive.
Acronym
Patient preferences for colonoscopy, CT colonography, and bowel preparation
Scientific Title
Patient preferences for colonoscopy, CT colonography, and bowel preparation: prospective comparative study in patients with fecal immunochemical test positive.
Scientific Title:Acronym
Patient preferences for colonoscopy, CT colonography, and bowel preparation
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 investigate preferences of colorectal screening examinations in patients with fecal immunochemical test positive.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient's voluntary choice for colorectal screening examinations
Key secondary outcomes
1.Evaluation of patient acceptance of colorectal screening examinations
2.Evaluation of patient preferences for the future colorectal screening examination
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Patients with inflammatory bowel disease.
2) Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
3) Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.
4) Previous colorectal surgery.
5) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
6) Evidence of an increased risk in carrying out bowel preparation or CTC exams.
7) Possibility of pregnancy.
8) Patients with psychological conditions that contraindicate colonoscopy or make them irrelevant to participate in the trial.
9) Claustrophobia.
10) Severe deafness.
11) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kato |
Organization
Hokkaido Gastroenterology Hospital
Division name
Department of Internal medicine
Zip code
Address
Honcho1jyo1chome Higashi-Ku,Sapporo,Japan
TEL
011-784-1811
tks-kato-42@hgh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi kato |
Organization
Hokkaido Gastroenterology Hospital
Division name
Department of Internal medicine
Zip code
Address
hgh-1@hgh.or.jp
TEL
011-784-1811
Homepage URL
tks-kato-42@hgh.or.jp
Sponsor or person
Institute
Hokkaido Gastroenterology Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Gastroenterology Hospital
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
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
医療法人彰和会 北海道消化器科病院（北海道）、医療法人社団 松愛会 松田病院（静岡県）、長崎県上五島病院（長崎県）、KKR札幌医療センター斗南病院（北海道）、川崎医科大学（岡山県）、福島県立医科大学・会津医療センター（福島県）、医療法人 まつおかクリニック（奈良県）、東京国際クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective observational study
Management information
Registered date
| 2012 | Year | 12 | Month | 02 | Day |
Last modified on
| 2015 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011104
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
