UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031540
Receipt number R000036013
Scientific Title A prospective observation study of predictive factors for short-term and long-term outcomes of patients with oesophagogastric cancer
Date of disclosure of the study information 2018/03/01
Last modified on 2023/09/04 09:15:10

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Basic information

Public title

A prospective observation study of predictive factors for short-term and long-term outcomes of patients with oesophagogastric cancer

Acronym

A prospective observation study of predictive factors in patients with oesophagogastric cancer

Scientific Title

A prospective observation study of predictive factors for short-term and long-term outcomes of patients with oesophagogastric cancer

Scientific Title:Acronym

A prospective observation study of predictive factors in patients with oesophagogastric cancer

Region

Japan


Condition

Condition

Oesophagogastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To identify predictive factors for short-term and long-term outcomes of patients with oesophagogastric cancer

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Predictive values of clinical factors for postoperative short-term and long-term outcomes

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

-Patients undergoing surgical resection of oesophagogastric cancer
-Aged 20 years or older
-Written informed consent

Key exclusion criteria

Any condition that makes the patient unsuitable for inclusion in the study according to the investigators

Target sample size

650


Research contact person

Name of lead principal investigator

1st name Yasuhiro
Middle name
Last name Kodera

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery (Surgery II)

Zip code

4668550

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2249

Email

m-kanda@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Mitsuro
Middle name
Last name Kanda

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery (Surgery II)

Zip code

4668550

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2249

Homepage URL


Email

m-kanda@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Institutional Review Board of Nagoya University

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

Tel

052-744-2479

Email

iga-sou1@adm.nagoya-u.ac.jp


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 03 Month 01 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

Enrolling by invitation

Date of protocol fixation

2018 Year 03 Month 01 Day

Date of IRB

2018 Year 02 Month 23 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2030 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Clinical data is collected prospectively to establish a database for this study.
Correlations between clinical parameters and postoperative outcomes are analyzed to identify predictive factors.


Management information

Registered date

2018 Year 03 Month 01 Day

Last modified on

2023 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036013


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name