UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038749 |
|---|---|
| Receipt number | R000044176 |
| Scientific Title | Prospective exploratory study about adenoma detection rate in patients with duodenal epithelial neoplasia |
| Date of disclosure of the study information | 2019/12/02 |
| Last modified on | 2024/07/02 10:10:38 |
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Basic information
Public title
The study for prevalence of colorectal tumor among duodenal tumor patients
Acronym
D-CAD study
Scientific Title
Prospective exploratory study about adenoma detection rate in patients with duodenal epithelial neoplasia
Scientific Title:Acronym
D-CAD study
Region
| Japan |
Condition
Condition
colorectal tumor, duodenal epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To unveil the adenoma detection rate in patients with duodenal epithelial neoplasia
Basic objectives2
Others
Basic objectives -Others
Epidemiological surveillance of disease prevalence
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The colorectal adenoma detection rate (ADR) in patients with duodenal epithelial neoplasia and with medical checkup
Key secondary outcomes
1) The ADR for each mucous phenotype (gastric type/intestinal type) in patients with DET
2) The polype detection rat (PDR) in patients with DET and with medical checkup, the PDR for each mucous phenotype (gastric type/intestinal type) in patients with DET
3) The percentage of advanced neoplasia (ex, adenoma over 10mm, adenoma with severe atypia, villous adenoma or adenocarcinoma) in patients with DET and with medical checkup, that percentage for each mucous phenotype (gastric type/intestinal type) in patients with DET
4) The percentage of colorectal cancer including advanced cancer in patients with DET and with medical checkup, that percentage for each mucous phenotype (gastric type/intestinal type) in patients with DET
5) The percentage of laterally spreading tumor (LST) in patients with DET and with medical checkup, that percentage for each mucous phenotype (gastric type/intestinal type) in patients with DET
6) The percentage of sessile serrated adenoma/polyp (SSA/P) in patients with DET and with medical checkup, that percentage for each mucous phenotype (gastric type/intestinal type) in patients with DET
7) The percentage of sessile serrated adenoma/polyp (SSA/P) in patients with DET and with medical checkup, that percentage for each mucous phenotype (gastric type/intestinal type) in patients with DET
8) The mean number of colorectal adenoma in patient with DET and with medical checkup, the mean number of that for each mucous phenotype (gastric type/intestinal type) in patients with DET
9) The mean number of colorectal polyp in each patient with DET and with medical checkup, the mean number of that for each mucous phenotype (gastric type/intestinal type) in patients with DET
10) The mean number of SSA/P in each patient with DET and with medical checkup, the mean number of that for each mucous phenotype (gastric type/intestinal type) in patients with DET
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<DET group>
The patient has been treated their DET by endoscopy (EMR, ESD, EP) or are scheduled to treat their DET in the future, who have not undergone colonoscopy until now, or who have passed 3 or more years since the previous colonoscopy.
<Medical checkup group>
The patient who undergone a colonoscopy at our hospital's medical dock, and it has passed 3 years or more after the examination.
Key exclusion criteria
1) The patient with family adenomatous polyposis and hereditary non-polyposis colorectal cancer
2) The patient with inflammatory bowel disease
3) The patient who has a history of colon surgery
4) The patient with abnormal blood coagulation function, or the patient who are unable to manage anticoagulant/platelet drugs according to the gastrointestinal endoscopy guidelines
5)Case of vital organ failure
6)The case judged by the attending physician as inappropriate for registration
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University of medicine
Division name
Gastroenterology/ Cancer center
Zip code
1608582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
0353633437
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Mizutani |
Organization
Keio University of medicine
Division name
Gastroenterology/ Cancer center
Zip code
1608582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
0353633437
Homepage URL
marimizutani6@keio.jp
Sponsor or person
Institute
Keio University of medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics committee of Keio University school of medicine
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel
0333531211
keio@esct.bvits.com
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
慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/products/ejournals/abstract/10.1055/a-2341-9026
Number of participants that the trial has enrolled
360
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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 05 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Colonoscopy for DET patients is performed as daily medical care. Of these, colonoscopy will be performed after obtaining consent for cases that meet the selection criteria and none of the exclusion criteria. The examination is done as usual, but all epithelial lesions found during the examination are removed endoscopically and submitted for pathology. There is no specific treatment method. Lesions that are judged not to be able to removed by endoscopy will be surgically removed at a later date, and the pathological results will be confirmed.
Management information
Registered date
| 2019 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044176
