UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038749
Receipt No. 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 2019/12/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 had 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
Email 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
Email marimizutani6@keio.jp

Sponsor
Institute Keio University of medicine
Institute
Department

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
Email 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 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 02 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
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
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044176

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.