UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043215 |
|---|---|
| Receipt number | R000049321 |
| Scientific Title | Retrospective observation study to investigate clinicopathological prognostic factors for pancreatic cancer |
| Date of disclosure of the study information | 2021/02/22 |
| Last modified on | 2021/02/01 20:53:19 |
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Basic information
Public title
Retrospective observation study to investigate clinicopathological prognostic factors for pancreatic cancer
Acronym
Retrospective observation study to investigate clinicopathological prognostic factors for pancreatic cancer
Scientific Title
Retrospective observation study to investigate clinicopathological prognostic factors for pancreatic cancer
Scientific Title:Acronym
Retrospective observation study to investigate clinicopathological prognostic factors for pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the clinicopathological prognostic factors for pancreatic ductal adenocarcinoma
Basic objectives2
Others
Basic objectives -Others
This study aims to clarify the clinicopathological prognostic factors for pancreatic ductal adenocarcinoma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prognostic factors for pancreatic ductal adenocarcinoma
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients received pancreaticoduodenectomy from Jan. 2000 to Feb. 2019 in wakayama medical university.
Key exclusion criteria
1) Patients refused to agree with this protocol.
2) The investigator judged the patient as appropriate for study subject.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Motoki |
| Middle name | |
| Last name | Miyazawa |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Japan
TEL
+81734410613
mo-0702@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Miyazawa |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Japan
TEL
+81734410613
Homepage URL
mo-0702@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera Wakayama, Japan
Tel
+81734410613
mo-0702@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
3079
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
和歌山県立医科大学
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 22 | 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
400
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Age, sex, height, weight, history of disease, imaging findings, laboratory data, surgical procedure, chemotherapy, pathological findings, the day of recurrence, the location of recurrence, prognosis.
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2021 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049321
