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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033806
Receipt No. R000038563
Scientific Title Blood biomarker of colorectal adenoma and early-stage adenocarcinoma
Date of disclosure of the study information 2018/08/19
Last modified on 2018/08/19

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Basic information
Public title Blood biomarker of colorectal adenoma and early-stage adenocarcinoma
Acronym Blood biomarker of colorectal tumor
Scientific Title Blood biomarker of colorectal adenoma and early-stage adenocarcinoma
Scientific Title:Acronym Blood biomarker of colorectal tumor
Region
Japan

Condition
Condition Colorectal adenoma and early-stage carcinoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 In japan, colorectal cancer ranks 1st in all cancer, but prevalence of fecal immnological test(FIT) is still around 30%, and even in examinees with positve FIT, only 50-60% of examinees undergo colonoscopy. In US, cologuard and sept9 have been approved by FDA, but they are not so sensitive in advanced adenoma and early-stage adenocarcinoma. In this study, we determine to identify the blood biomarker which detect advanced adenoma and early stage adenocarcinoma.
Basic objectives2 Others
Basic objectives -Others Identification of blood biomarker of colorectal adenoma and early-stage adenocariconma
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Sensitivity, specifity, and accuracy of the identified blood biomarker
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Endoscopic resection
Interventions/Control_2 Healthy participants
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with high-grade adenoma and early-stage adenocaricnoma with >9mm in size who will undergo endoscopic resection.
Key exclusion criteria 1. Pregnant women
2. Patients with small and large bowel stricture
3. inappropriate patients to enroll judged by doctors
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9240
Email nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9240
Homepage URL
Email nohmiya@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine, Department of Gastroenterology
Institute
Department

Funding Source
Organization Aichi Cancer Research Foundation
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Aichi Cancer Center Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 藤田保健衛生大学消化管内科(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 19 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
Enrollent is ongoing.
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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 06 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 10 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 19 Day
Last modified on
2018 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038563

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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