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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007271
Receipt No. R000008578
Scientific Title Multicenter study on the clinical usefulness of a new method diagnosing earlier development of pancreatic fibrosis, which targets proteolytic TGF-B-activation reaction.
Date of disclosure of the study information 2012/02/13
Last modified on 2012/02/12

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Basic information
Public title Multicenter study on the clinical usefulness of a new method diagnosing earlier development of pancreatic fibrosis, which targets proteolytic TGF-B-activation reaction.
Acronym Multicenter study on diagnostic usefulness of TGF-B LAP-D for early stage of chronic pancreatitis.
Scientific Title Multicenter study on the clinical usefulness of a new method diagnosing earlier development of pancreatic fibrosis, which targets proteolytic TGF-B-activation reaction.
Scientific Title:Acronym Multicenter study on diagnostic usefulness of TGF-B LAP-D for early stage of chronic pancreatitis.
Region
Japan

Condition
Condition Chronic pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the usefulness of TGF-B LAP-D in the diagnosis of early stage of chronic pancreatitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To study whether the level of TGF-B LAP-D correlates with the stage of chronic pancreatitis.
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients matching definite chronic pancreatitis, probable chronic pancreatitis, early chronic pancreatitis, possible chronic pancreatitis or possible early chronic pancreatitis according to the Japanese clinical diagnostic criteria 2009.
2. Patients with Performance Status 0-1.
3. Patients without major organ insufficiency.
4. Patients with written and oral informed consent.
Key exclusion criteria 1. Patients with infections, difficult to control, for examples active tuberculosis.
2. Patients with severe drug allergy.
3. Patients with difficulty in the performance of endoscopy.
4. Patients with malignancy.
5. Patients with history of anticancer drug.
6. Patients with possible causes developing hepatic fibrosis without alcohol consumption, such as, viral hepatitis, autoimmune hepatitis,non-alcoholic steatohepatitis, and CBD stones etc.
7. Patients with two times or more of the level of normal alanine transaminase (ALT).
8. Patients with interstitial pneumoniae and lung fibrosis.
9. Patients with severe complications.
10. Patients with pregnancy, lactating, possibility of pregnancy, or will of pregnancy.
11. Patients with severe mental disorder.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65, Tsuruma-Cho, Showa-Ku, Nagoya, Aichi, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65, Tsuruma-Cho, Showa-Ku, Nagoya, Aichi, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 02 Month 13 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 Open public recruiting
Date of protocol fixation
2012 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Major assessment:
To verify the usefulness of TGF-B LAP-D in the diagnosis of early stage of chronic pancreatitis.
Minor assessment:
To verify the usefulness of TGF-B LAP-D in the diagnosis of pancreatic fibrosis.

Management information
Registered date
2012 Year 02 Month 12 Day
Last modified on
2012 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008578

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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