UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034462 |
|---|---|
| Receipt number | R000039266 |
| Scientific Title | Bone fracture in patients receiving chemotherapy for gastrointestinal cancer. |
| Date of disclosure of the study information | 2018/10/20 |
| Last modified on | 2018/10/12 12:45:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Bone fracture in patients receiving chemotherapy for gastrointestinal cancer.
Acronym
Bone fracture in patients receiving chemotherapy for gastrointestinal cancer.
Scientific Title
Bone fracture in patients receiving chemotherapy for gastrointestinal cancer.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takayuki Sone |
Organization
Sapporo City General Hospital
Division name
Gastroenterology
Zip code
Address
1-1, Nishi 13 chome, Kita 11 jo, Chuo-ku, Sapporo, JAPAN
TEL
011-726-2211
takayuki.sone@doc.city.sapporo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Sakai |
Organization
Sapporo City General Hospital
Division name
Gastroenterology
Zip code
Address
1-1, Nishi 13 chome, Kita 11 jo, Chuo-ku, Sapporo, JAPAN
TEL
011-726-2211
Homepage URL
yuko.sakai@city.sapporo.jp
Sponsor or person
Institute
Sapporo City General Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 26 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039266
