UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049664 |
|---|---|
| Receipt number | R000056138 |
| Scientific Title | A multicenter study of short- and long-term outcomes in operable pancreatic cancer |
| Date of disclosure of the study information | 2022/12/05 |
| Last modified on | 2024/12/03 14:54:28 |
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Basic information
Public title
A multicenter study of short- and long-term outcomes in operable pancreatic cancer
Acronym
A multicenter study of short- and long-term outcomes in operable pancreatic cancer
Scientific Title
A multicenter study of short- and long-term outcomes in operable pancreatic cancer
Scientific Title:Acronym
A multicenter study of short- and long-term outcomes in operable pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to identify preoperative factors predictive of poor prognosis and predictive factors for optimal preoperative treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Study 1: To examine biological Borderline Resectable (BR) patients in anatomical Resectable (R) patients of pancreatic cancer
Study 2: Effect of changes in CA19-9 levels after preoperative treatment on recurrence and survival
Study 3: Evaluation of the Usefulness of serum DUPAN-2 for CA19-9 Non-secretors with Pancreatic Cancer
Study 4: An Exploratory study of optimal preoperative treatment for patients with borderline resectable (BR-A) pancreatic cancer
Study 5: An Exploratory study of Risk Factors for Perioperative Complications related to Preoperative Therapy
Study 6: Analysis of the significance of reticular pattern around superior mesenteric artery in computed tomography of R/BR pancreatic cancer and the effect of preoperative Therapy
Study 7: Relationship between ABO blood type and survival outcome after pancreatectomy for pancreatic cancer
Study 8: Significance of metastasectomy in patients with recurrent pancreatic cancer after pancreatectomy
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Pancreatic cancer patients who were diagnosed as R, BR-PV, or BR-A of the resectability classification in the General Rules for the study of Pancreatic cancer (the 7th edition) from Japan pancreatic society.
2. Patients who have not requested refusal by the research subject or by a person who is considered to represent the will and interests of the research subject.
3. 20 years or older.
Key exclusion criteria
1. Patients who do not meet the above inclusion criteria
2. Patients with insufficient clinical data
3. Patients deemed inappropriate as research subjects by the principal investigator
Target sample size
2650
Research contact person
Name of lead principal investigator
| 1st name | Kimitaka |
| Middle name | |
| Last name | Tanaka |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterological surgery 2
Zip code
0608638
Address
Kita-ku North 15 West 7, Sapporo, Hokkaido, Japan
TEL
011-706-7714
kimitaka.t@gmail.com
Public contact
Name of contact person
| 1st name | Kimitaka |
| Middle name | |
| Last name | Tanaka |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterological surgery 2
Zip code
0608638
Address
Kita-ku North 15 West 7, Sapporo, Hokkaido, Japan
TEL
011-706-7714
Homepage URL
kimitaka.t@gmail.com
Sponsor or person
Institute
Department of Gastroenterological surgery 2, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological surgery 2, Hokkaido University Hospital
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita-ku North 15 West 5, Sapporo, Hokkaido, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.ac.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
| 2022 | Year | 12 | Month | 05 | 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
| 2022 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2022 | Year | 12 | Month | 01 | Day |
Last modified on
| 2024 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056138
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/08/12 | ［生021-0184］研究計画書ver1.4F.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/08/12 | HPB-SNOW data specifications Ver1.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/08/12 | 240810UMIN.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/56138
