UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033806 |
|---|---|
| Receipt number | 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 23:32:27 |
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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
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
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine, Department of Gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038563
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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