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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035437
Receipt No. R000040370
Scientific Title A multi-institutional prospective cohort study of employment after colorectal cancer surgery
Date of disclosure of the study information 2019/05/07
Last modified on 2019/07/07

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Basic information
Public title A multi-institutional prospective cohort study of employment after colorectal cancer surgery
Acronym A multi-institutional prospective cohort study of employment after colorectal cancer surgery
Scientific Title A multi-institutional prospective cohort study of employment after colorectal cancer surgery
Scientific Title:Acronym A multi-institutional prospective cohort study of employment after colorectal cancer surgery
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Our study aims are 1: to clarify the proportion of working patient and 2: to explore risk factors for returning to work, one year after surgery.
Basic objectives2 Others
Basic objectives -Others To estimate proportion
To explore risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of working patients one year after surgery
Key secondary outcomes 1) Time from surgery to returning to work
2) Proportion of employed patients one year after surgery

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 1) cStage I, II, or III colorectal cancer
2) planning curative surgery
3) employed at the time of diagnosis
4) obtained consent by the document
Key exclusion criteria 1) undergoing chemotherapy for other cancers
2) judged inappropriate by the examining doctor
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Yoshiharu
Middle name
Last name Sakai
Organization Kyoto University
Division name Gastrointestinal surgery
Zip code 6068507
Address 54, Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-366-7595
Email ysakai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Fujita
Organization Kyoto University
Division name Gastrointestinal surgery
Zip code 6068507
Address 54, Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-366-7595
Homepage URL
Email 0424.yusuke@gmail.com

Sponsor
Institute Department of Gastrointestinal Surgery, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization The Mitsubishi foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address 54, Kawahara-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-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
2019 Year 05 Month 07 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 Preinitiation
Date of protocol fixation
2018 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2021 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We estimate the proportion of working patients one year after surgery. We estimate the proportion of employed patients in the same way. We estimate the time from surgery to returning to work with the Kaplan-Meier method.
We explore the influence of clinical factors and socioeconomic factors on returning to work by estimating their risk ratio and odds ratio. In particular, when we explore the effects of adjuvant chemotherapy, we focus on patients with pStageII, III.

Management information
Registered date
2019 Year 01 Month 04 Day
Last modified on
2019 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040370

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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