UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bone fracture in patients receiving chemotherapy for gastrointestinal cancer.
Title of the study (Brief title)	Bone fracture in patients receiving chemotherapy for gastrointestinal cancer.
Region	Japan

Condition
Condition	Gastrointestinal tract cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We analyzed the patients who had a bone fracture during cancer chemotherapy by reviewing clinical records and identified the association between survival time and bone fracture events.
Basic objectives2	Others
Basic objectives -Others	retrospective cohort study
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	overall survival time after fracture
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	In total, 182 colorectal cancer patients who received chemotherapy between January 2008 and December 2016 in our institution were enrolled. We investigated the prognosis of the 15 patients who suffered bone fractures after chemotherapy induction.
Key exclusion criteria	none
Target sample size	15

Research contact person
Name of lead principal investigator	Takayuki Sone
Organization	Sapporo City General Hospital
Division name	Gastroenterology
Address	1-1, Nishi 13 chome, Kita 11 jo, Chuo-ku, Sapporo, JAPAN
TEL	011-726-2211
Email	takayuki.sone@doc.city.sapporo.jp

Public contact
Name of contact person	Yuko Sakai
Organization	Sapporo City General Hospital
Division name	Gastroenterology
Address	1-1, Nishi 13 chome, Kita 11 jo, Chuo-ku, Sapporo, JAPAN
TEL	011-726-2211
Homepage URL
Email	yuko.sakai@city.sapporo.jp

Sponsor
Institute	Sapporo City General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 10 Month 20 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 10 Month 26 Day
Anticipated trial start date	2017 Year 10 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	182 colorectal cancer patients who received chemotherapy between January 2008 and December 2016 in our institution were enrolled. We investigated the prognosis of the 15 patients who suffered bone fractures after chemotherapy induction.

Management information
Registered date	2018 Year 10 Month 12 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039266