UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007271 |
|---|---|
| Receipt number | 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 20:00:42 |
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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
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
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008578
