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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018914
Receipt No. R000021883
Scientific Title Clinical trial of colon cancer diagnostic reagent by blood mRNA examination for practical use
Date of disclosure of the study information 2015/09/04
Last modified on 2018/09/06

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Basic information
Public title Clinical trial of colon cancer diagnostic reagent by blood mRNA examination for practical use
Acronym Clinical trial of colon cancer diagnostic pharmaceutical by blood mRNA examination
Scientific Title Clinical trial of colon cancer diagnostic reagent by blood mRNA examination for practical use
Scientific Title:Acronym Clinical trial of colon cancer diagnostic pharmaceutical by blood mRNA examination
Region
Japan

Condition
Condition colon cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is assessment of diagnostic efficacy of extracorporeal diagnostic reagent "colon cancer diagnosis kit"(investigation reagent code: KaNa-Co01) whose principle is measurement of gene expression which is affected in colon cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes sensitivity, specificity
Key secondary outcomes positive predictive value and negative predictive value of stool occult blood test.
positive predictive value and negative predictive value of blood mRNA test.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet the criteria below will be enrolled. Gender, admission/outpatient clinic will not be assessed.
1) Patients who undergo total colonoscopy examination
2) Patients aged more than 20 years when informed consent is obtained.
3) Patients who give the informed consent.

Colon cancer 100 patients and non-colon cancer 100 cases will be enrolled.
Key exclusion criteria The patients who meet any of the criteria below will be excluded.
1) Patients who have been diagnosed with malignancy within 5 year of the date of the informed consent.
2) Patients who have been treated with interferon treatment within one year of the date of the informed consent, or is currently undergoing interferon treatment.
3) Patients who have been treated with adrenal hormone (except for local treatment) or biological drug (etc. infliximab) within 6 months.
4) Patients who have been treated with anti-cancer drug within 6 months of the informred consent.
5) Patients who are infected with hepatitis B, hepatitis C or other infectious diseases.
6) Patients who have been diagnosed with irritable bowel syndrome, ulcerative colitis, and Crohn disease.
7)Patients, who are judged to be not appropriate for entry by the trial responsible (collaborative) doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Kaneko
Organization Kanazawa University
Division name school of medicine
Zip code
Address 13-1 Takara-machi, Kanazawa-shi, Ishikawa
TEL 076-265-2233
Email skaneko@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Sakai
Organization Kanazawa University
Division name school of medicine
Zip code
Address 13-1 Takara-machi, Kanazawa-shi, Ishikawa
TEL 076-265-2235
Homepage URL
Email yoshios@m-kanazawa.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization AMED
KUBIX Inc.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 04 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 Completed
Date of protocol fixation
2015 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 27 Day
Last follow-up date
Date of closure to data entry
2017 Year 05 Month 31 Day
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information Patients who undergo total colonoscopic examination will be prospectively enrolled. A hundred colon cancer patients and a hundred non-colon cancer patients will be enrolled.

Patients who meet the criteria below will be enrolled. Gender, admission/outpatient clinic will not be assessed.
1) Patients who undergo total colonoscopy examination
2) Patients aged more than 20 years when informed consent is obtained.
3) Patients who give the informed consent.

The patients who meet any of the criteria below will be excluded.
1) Patients who have been diagnosed with malignancy within 5 year of the date of the informed consent.
2) Patients who have been treated with interferon treatment within one year of the date of the informed consent, or is currently undergoing interferon treatment.
3) Patients who have been treated with adrenal hormone (except for local treatment) or biological drug (etc. infliximab) within 6 months.
4) Patients who have been treated with anti-cancer drug within 6 months of the informred consent.
5) Patients who are infected with hepatitis B, hepatitis C or other infectious diseases.
6) Patients who have been diagnosed with irritable bowel syndrome, ulcerative colitis, and Crohn disease.
7)Patients, who are judged to be not appropriate for entry by the trial responsible (collaborative) doctor

Management information
Registered date
2015 Year 09 Month 04 Day
Last modified on
2018 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021883

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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