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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034453
Receipt No. 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

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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
Email 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
Email chtakagi@tochigi-cc.jp

Sponsor
Institute Tochigi Cancer Center
Institute
Department

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
Email

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
URL(English) https://upload.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


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