UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034453 |
|---|---|
| Receipt number | R000039271 |
| Scientific Title | Clinical implications of postoperative carbohydrate antigen 19-9 as a serological indicator of positive resection margin and occult distant metastasis in patients with resected pancreatic cancer |
| Date of disclosure of the study information | 2018/10/11 |
| Last modified on | 2018/10/11 16:54:27 |
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Basic information
Public title
Clinical implications of postoperative carbohydrate antigen 19-9 as a serological indicator of positive resection margin and occult distant metastasis in patients with resected pancreatic cancer
Acronym
Clinical implications of postoperative carbohydrate antigen 19-9 in patients with resected pancreatic cancer
Scientific Title
Clinical implications of postoperative carbohydrate antigen 19-9 as a serological indicator of positive resection margin and occult distant metastasis in patients with resected pancreatic cancer
Scientific Title:Acronym
Clinical implications of postoperative carbohydrate antigen 19-9 in patients with resected 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
To investigate the prognostic value of elevated Post-CA 19-9 and its preoperative and postoperative clinical significance in patients with macroscopically resectable pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Independent prognostic factors were identified using univariate and multivariate Cox-proportional hazard models including pathological and postoperative clinical variables.
Key secondary outcomes
Univariate and multivariate logistic regression analysis were used to identify factors that were independent predictive factors of elevated Post-CA 19-9.
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
Patients with surgical resection for pancreatic ductal adenocarcinoma between January 2008 and December 2016 were included in the analysis.
Key exclusion criteria
Patients with macroscopically positive resection margin or distant metastasis were excluded.
Patients with Pre-CA 19-9 < 5 U/ml were excluded.
CA 19-9 values were not included in the analysis if serum total bilirubin was >2.0 mg/dl at the time of assay.
Target sample size
166
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takagi Chisato |
Organization
Tochigi Cancer Center
Division name
Hepato-Biliary-Pancreatic Surgery
Zip code
Address
4-9-13, Yohnan, Utsunomiya, Tochigi 320-0834, Japan
TEL
028-658-5151
chtakagi@tochigi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takagi Chisato |
Organization
Tochigi Cancer Center
Division name
Hepato-Biliary-Pancreatic Surgery
Zip code
Address
4-9-13, Yohnan, Utsunomiya, Tochigi 320-0834, Japan
TEL
028-658-5151
Homepage URL
chtakagi@tochigi-cc.jp
Sponsor or person
Institute
Tochigi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 10 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | 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
This is a retrospective cohort study evaluated patient data collected at the Tochigi Cancer Center.
Patients with surgical resection for PDCA between January 2008 and December 2016 were included in the analysis.
Management information
Registered date
| 2018 | Year | 10 | Month | 11 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039271
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/10/11 | ad2008.csv |
