UMIN-CTR Clinical Trial

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
Email	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
Email	mo-0702@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049321

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.