UMIN-CTR Clinical Trial

Basic information
Public title	Impact of distance to the hospital on mortality in metastatic colorectal cancer patients in chemotherapy
Acronym	Impact of distance to the hospital on mortality in metastatic colorectal cancer patients in chemotherapy
Scientific Title	Impact of distance to the hospital on mortality in metastatic colorectal cancer patients in chemotherapy
Scientific Title:Acronym	Impact of distance to the hospital on mortality in metastatic colorectal cancer patients in chemotherapy
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Surgery in general Gastrointestinal surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the impact of travel distance to prognosis of mCRC patients in chemotherapy
Basic objectives2	Others
Basic objectives -Others	To investigate the impact of travel distance to prognosis of mCRC patients in chemotherapy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall Survival
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	120 years-old >=
Gender	Male and Female
Key inclusion criteria	Histologically confirmed cases of colorectal adenocarcinoma Cases diagnosed as synchronous mCRC by image findings and surgical findings before treatment Cases in which systemic chemotherapy was performed
Key exclusion criteria	Cases in which neoadjuvant chemotherapy was performed Appendix cancer
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Shunichi Middle name Last name Fukuhara
Organization	Kyoto University
Division name	Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine
Zip code	6068501
Address	Yoshida Konoe cho, Sakyo, Kyoto
TEL	+81-7-5754-9467
Email	fukuhara.shunichi.6m@kyoto-u.ac.jp

Public contact
Name of contact person	1st name Hidetaka Middle name Last name Kawamura
Organization	Fukushima Medical University
Division name	Department of Minimally Invasive Surgical and Medical Oncology
Zip code	963-856
Address	7-115 Yatsuyamada, Koriyama, Fukushima
TEL	0249345322
Homepage URL
Email	hidetaka0716.hk@gmail.com

Sponsor
Institute	Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto 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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2019-170
Org. issuing International ID_1	Fukushima Medical University
Study ID_2	397
Org. issuing International ID_2	Southern TOHOKU General Hospital
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 10 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	Open public recruiting
Date of protocol fixation	2019 Year 09 Month 01 Day
Date of IRB	2019 Year 11 Month 01 Day
Anticipated trial start date	2019 Year 11 Month 02 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We investigate the impact of travel distance to prognosis of mCRC patients in chemotherapy

Management information
Registered date	2020 Year 09 Month 24 Day
Last modified on	2020 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047801