UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020758 |
|---|---|
| Receipt number | R000023938 |
| Scientific Title | Clinical trial of pancreatic cancer diagnostic reagent by blood mRNA examination for practical use |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2019/06/29 15:20:14 |
* 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 pancreatic cancer diagnostic reagent by blood mRNA examination for practical use
Acronym
Clinical trial of pancreatic cancer diagnostic pharmaceutical by blood mRNA examination
Scientific Title
Clinical trial of pancreatic cancer diagnostic reagent by blood mRNA examination for practical use
Scientific Title:Acronym
Clinical trial of pancreatic cancer diagnostic pharmaceutical by blood mRNA examination
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is assessment of diagnostic efficacy of extracorporeal diagnostic reagent "pancreatic cancer diagnosis kit" (investigation reagent code: KaNa-PK01) whose principle is measurement of gene expression affected in pancreatic 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
1. positive predictive value and negative predictive value of blood mRNA test
2. sensitivity, specificity, positive predictive value and negative predictive value of CEA
3. sensitivity, specificity, positive predictive value and negative predictive value of CA19-9
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria below when they are registered. Gender, admission or outpatient clinic will not be assessed.
1. pancreas cancer patient, chronic pancreatitis patient, intraductal papillary mucinous neoplasm, healthy individual.
<in case of pancreatic cancer patients>
patients who are diagnosed to be pancreatic cancer by image or pathology.
<in case of chronic pancreatitis, intraductal papillary mucinous neoplasm>
patients who are diagnosed with chronic pancreatitis or intraductal papillary mucinous neoplasm by image or pathology.
<in case of healthy individual>
the individual who comes to undergo medical check-up and is considered to be healthy judged from the history by the previous year and diagnostic questionnaire on the day of medical check-up.
2. Patients aged more than equal 40 years and less than 90 years old.
3. Patients who give the informed consent.
Key exclusion criteria
The patients who meet any of the criteria below will be excluded when they are registered.
1. Patients who have been diagnosed with malignancy(excluding pancreatic cancer) within 5 years of the date of the informed consent.
2. Patients who have been or is currently treated with immunosuppressant, oral steroid within one year of the date of the informed consent.
3. Patients who have been treated with anti-cancer drug within 6 months of the date of the informed consent.
4. Patients who are infected with hepatitis B, hepatitis C or other infectious diseases.
5. Patients who are judged to be not appropriate for entry by the trial responsible (collaborative) doctor.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Kaneko |
Organization
Kanazawa University
Division name
school of medicine
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa-shi, Ishikawa, Japan.
TEL
076-265-2233
skaneko@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Sakai |
Organization
Kanazawa University
Division name
school of medicine
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa-shi, Ishikawa, Japan.
TEL
076-265-2235
Homepage URL
yoshios@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
KUBIX Inc.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa University
Address
13-1 Takara-machi, Kanazawa
Tel
076-265-2090
irb@adm.kanazawa-u.ac.jp
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
金沢大学
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1111/cas.13971
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/cas.13971
Number of participants that the trial has enrolled
205
Results
The sensitivity of the system for PDAC diagnosis was 73.6% (95% confidence interval, 59.7%-84.7%). The specificity for noncancer volunteers, chronic pancreatitis, and patients with intraductal papillary neoplasms was 643.7% (54.6%-73.9%), 63.6% (40.7%-82.8%), and 47.8% (26.8%-69.4%), respectively. Importantly, the sensitivity of this system for both stage I and stage II PDAC was 78.6%(57.1%-100%).
Results date posted
| 2019 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 02 | Month | 11 | Day |
Baseline Characteristics
pancreas ductular adenocarcinoma, noncancer volunteers, chronic pancreatitis, and patients with intraductal papillary mucinous neoplasms
Participant flow
The eligible objectives who provide written informed consent to this study are registered, and blood mRNA measurement system judgement is performed.
Adverse events
nothing
Outcome measures
Primary Endpoint: sensitivity, specificity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 19 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 19 | Day |
Other
Other related information
Patients who meet all of the following criteria below when they are registered. Gender, admission or outpatient clinic will not be assessed.
1. pancreas cancer patient, chronic pancreatitis patient, intraductal papillary mucinous neoplasm, healthy individual.
<in case of pancreatic cancer patients>
patients who are diagnosed to be pancreatic cancer by image or pathology.
<in case of chronic pancreatitis, intraductal papillary mucinous neoplasm>
patients who are diagnosed with chronic pancreatitis or intraductal papillary mucinous neoplasm by image or pathology.
<in case of healthy individual>
the individual who comes to undergo medical check-up and is considered to be healthy judged from the history by the previous year and diagnostic questionnaire on the day of medical check-up.
2. Patients aged more than equal 40 years and less than 90 years old.
3. Patients who give the informed consent.
Management information
Registered date
| 2016 | Year | 01 | Month | 27 | Day |
Last modified on
| 2019 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023938
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
