UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Blood biomarker of colorectal adenoma and early-stage adenocarcinoma
Title of the study (Brief title)	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	Naoki Ohmiya
Organization	Fujita Health University School of Medicine
Division name	Department of Gastroenterology
Address	1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL	0562-93-9240
Email	nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person	Naoki Ohmiya
Organization	Fujita Health University
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 02 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Enrollent is ongoing.
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