UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011478 |
|---|---|
| Receipt number | R000013378 |
| Scientific Title | Analysis of the association between the serum autoantibodies and the prognosis of patients with pancreatic cancer |
| Date of disclosure of the study information | 2013/08/13 |
| Last modified on | 2024/02/20 08:54:02 |
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Basic information
Public title
Analysis of the association between the serum autoantibodies and the prognosis of patients with pancreatic cancer
Acronym
The serum autoantibodies and the prognosis of patients with pancreatic cancer
Scientific Title
Analysis of the association between the serum autoantibodies and the prognosis of patients with pancreatic cancer
Scientific Title:Acronym
The serum autoantibodies and the prognosis of patients with pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between the serum autoantibodies and the prognosis of patients with pancreatic cancer
Basic objectives2
Others
Basic objectives -Others
Usefulness of serum autoantibodies as biomarkers
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Disease-free survival
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.Written informed consent is acquired from all patients or proxies ofthe patients.
2.The age of the patients is from 20 to 80.
3.Patients with pathologically proven pancreatic cancer
4.Patients who receive surgical resection, chemotherapy, and/or chemoradiotherapy
Key exclusion criteria
1.Patients with an active concomitant malignancy
2.Estimated suvaival<1 month
3.Patients with severe heart, respiratory or liver failure
4.Patients with administration of steroids, immunosuppresive drugs or biological products
5.Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Miyake |
Organization
Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences
Division name
Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho Okayama, Japan
TEL
+81-86-235-7219
miyakeyasuhiro@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironari Kato |
Organization
Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences
Division name
Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho Okayama, Japan
TEL
+81-86-235-7219
Homepage URL
drkatocha@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
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
| 2013 | Year | 08 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study in which we evaluate the association between the serum antibodies and the prognosis of patients with pancreatic cancer
Management information
Registered date
| 2013 | Year | 08 | Month | 13 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013378
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| Registered date | File name |
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| Registered date | File name |
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