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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037117
Receipt No. R000042293
Scientific Title Cost analysis of bone fracture in patients with gastrointestinal cancer receiving chemotherapy
Date of disclosure of the study information 2019/06/19
Last modified on 2019/09/30

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Basic information
Public title Cost analysis of bone fracture in patients with gastrointestinal cancer receiving chemotherapy
Acronym Cost analysis of bone fracture in gastrointestinal cancer patients receiving chemotherapy
Scientific Title Cost analysis of bone fracture in patients with gastrointestinal cancer receiving chemotherapy
Scientific Title:Acronym Cost analysis of bone fracture in gastrointestinal cancer patients receiving chemotherapy
Region
Japan

Condition
Condition colorectal cancer, gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigated the cost caused by fracture in patients with gastrointestinal cancer who had received chemotherapy.
Basic objectives2 Others
Basic objectives -Others Medical costs
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Medical costs, survival time after fractures
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 The cases that gastrointestinal cancer patients receiving chemotherapy had fractures
Key exclusion criteria The case that the cost information cannot confirm from a medical fee bills enough
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Sone
Organization Sapporo City General Hospital
Division name Department of Gastroenterology
Zip code 060-8604
Address 1-1 Kita 13 Nishi 11, Chuo-ku, Sapporo, Japan
TEL 011-726-2211
Email takayuki_sone@icloud.com

Public contact
Name of contact person
1st name Takayuki
Middle name
Last name Sone
Organization Sapporo City General Hospital
Division name Department of Gastroenterology
Zip code 060-8604
Address 1-1 Kita 13 Nishi 11, Chuo-ku, Sapporo, Japan
TEL 011-726-2211
Homepage URL
Email takayuki_sone@icloud.com

Sponsor
Institute Sapporo City General Hospital
Institute
Department

Funding Source
Organization None
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 Sapporo City General Hospital
Address 1-1 Kita 13 Nishi 11, Chuo-ku, Sapporo, Japan
Tel 011-726-2211
Email ho.shomu@city.sapporo.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 06 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 29
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 Completed
Date of protocol fixation
2018 Year 12 Month 03 Day
Date of IRB
2018 Year 12 Month 07 Day
Anticipated trial start date
2018 Year 12 Month 07 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In periods from January, 2008 to December, 2018

Management information
Registered date
2019 Year 06 Month 19 Day
Last modified on
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042293

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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