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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043215
Receipt No. R000049321
Scientific Title Retrospective observation study to investigate clinicopathological prognostic factors for pancreatic cancer
Date of disclosure of the study information 2021/02/22
Last modified on 2021/02/01

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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


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