UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049693 |
|---|---|
| Receipt number | R000056601 |
| Scientific Title | Preoperative predictors of occult metastases in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma |
| Date of disclosure of the study information | 2022/12/05 |
| Last modified on | 2022/12/05 15:10:07 |
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Basic information
Public title
Preoperative predictors of occult metastases in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Acronym
Predictors of occult metastases in R and BR PDAC
Scientific Title
Preoperative predictors of occult metastases in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Scientific Title:Acronym
Predictors of occult metastases in R and BR PDAC
Region
| Japan |
Condition
Condition
pancreatic ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to identify preoperative predictors of occult metastases (OM), defined as distant metastases identified at surgery or within 6 months after pancreatectomy.
Basic objectives2
Others
Basic objectives -Others
Clarify the prognostic impact of OM
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Significant predictors of OM
Key secondary outcomes
Prognostic analysis by presence or absence of OM
Diagnostic accuracy of OM by predictors
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who were planned for radical pancreatectomy at Sapporo Medical University
2) Pathologically or cytologically proven diagnosis of PDAC
3) Patients with R and BR PDAC
Key exclusion criteria
1) Patients who underwent staging laparoscopy because of ascites or nodules suspected of peritoneal dissemination on MDCT
2) Patients with CA19-9 levels < 2 U/mL
3) Patients with < 6 months of follow-up despite the absence of OM
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Murakami |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
0600061
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan
TEL
0116112111
murakami.takeshi@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Murakami |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
0600061
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan
TEL
0116112111
Homepage URL
murakami.takeshi@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Department of Surgery, Surgical Oncology and Science
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Sapporo Medical University Department of Surgery, Surgical Oncology and Science
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan
Tel
0116112111
murakami.takeshii@sapmed.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
札幌医科大学病院（北海道）
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
279
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 | 02 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observation study
Management information
Registered date
| 2022 | Year | 12 | Month | 05 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056601
