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 2023/12/04 11:45:56

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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

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 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

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

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

No longer recruiting

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

2023 Year 12 Month 04 Day



Link to view the page

Value
https://center6.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