UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022063
Receipt number R000025432
Scientific Title A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer
Date of disclosure of the study information 2016/07/01
Last modified on 2023/10/31 09:13:55

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Basic information

Public title

A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer

Acronym

Serum miRNA panel in the diagnosis of pancreatobiliary cancer

Scientific Title

A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer

Scientific Title:Acronym

Serum miRNA panel in the diagnosis of pancreatobiliary cancer

Region

Japan


Condition

Condition

Pancreatobiliary cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the diagnostic value of serum microRNA panel versus CA19-9 in pancreatic and biliary tract cancer, prospectively

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

1. In discriminating pancreatobiliary cancer from healthy control, non-inferiority of specificity of serum miRNA panel when comparing the reported CA19-9 data (90-95%) and superiority of sensitivity of serum miRNA panel when comparing CA19-9
2. In discriminating pancreatobiliary cancer from inflammatory pancreatobiliary disease, non-inferiority of sensitivity of serum miRNA panel when comparing the reported CA19-9 data (70-80%) and superiority of specificity of serum miRNA panel when comparing CA19-9

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

healty subjects, patients with inflammatory pancreatobiliary disease, or patients with pancreatobiliary cancer or gastrointestinal cancer

Key exclusion criteria

patients with inflammatory pancreatobiliary disease and malignant disease, patients with anti-cancer treatment for cancer

Target sample size

1280


Research contact person

Name of lead principal investigator

1st name Shuichi
Middle name
Last name Mitsunaga

Organization

National Cancer Center Hospital East

Division name

Department of Hepatobiliary and Pancreatic Oncology

Zip code

277-8577

Address

6-5-1, Kashiwanoha, Chiba

TEL

+81-7133-1111

Email

mokojima@east.ncc.go.jp


Public contact

Name of contact person

1st name Shuichi
Middle name
Last name Mitsunaga

Organization

National Cancer Center Hospital East

Division name

Deparment of Hepatobiliary and Pancreatic Oncology

Zip code

277-8577

Address

6-5-1, Kashiwanoha, Chiba

TEL

+81-7133-1111

Homepage URL


Email

smitsuna@east.ncc.go.jp


Sponsor or person

Institute

Japan Agency for Medical Research and Development

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1 Tsukiji, Chuo-kuTokyo, 104-0045 Japan

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.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



Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 01 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

1487

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Main article in progress

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

No longer recruiting

Date of protocol fixation

2016 Year 04 Month 18 Day

Date of IRB

2020 Year 01 Month 22 Day

Anticipated trial start date

2020 Year 02 Month 28 Day

Last follow-up date

2020 Year 12 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 06 Month 19 Day


Other

Other related information

Trial registration was resumed in 2018.


Management information

Registered date

2016 Year 04 Month 25 Day

Last modified on

2023 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025432


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name