UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043215
Receipt number 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 20:53:19

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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 or person

Institute

Wakayama Medical University

Institute

Department

Personal name



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

Value
https://center6.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