UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018914 |
|---|---|
| Receipt number | 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 15:41:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yoshios@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
