UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041877
Receipt number R000047801
Scientific Title Impact of distance to the hospital on mortality in metastatic colorectal cancer patients in chemotherapy
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/24 06:10:51

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047801


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name