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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020758
Receipt No. 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

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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
Email 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
Email yoshios@m-kanazawa.jp

Sponsor
Institute Kanazawa University
Institute
Department

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
Email 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
URL(English) https://upload.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


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