UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of colon cancer diagnostic reagent by blood mRNA examination for practical use
Title of the study (Brief title)	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	Shuichi Kaneko
Organization	Kanazawa University
Division name	school of medicine
Address	13-1 Takara-machi, Kanazawa-shi, Ishikawa
TEL	076-265-2233
Email	skaneko@m-kanazawa.jp

Public contact
Name of contact person	Yoshio Sakai
Organization	Kanazawa University
Division name	school of medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021883