UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008899 |
|---|---|
| Receipt number | R000010440 |
| Scientific Title | A retrospective analysis of nail alterations due to low dose docetaxel via metronomic schedule. |
| Date of disclosure of the study information | 2012/09/13 |
| Last modified on | 2013/03/21 10:16:56 |
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Basic information
Public title
A retrospective analysis of nail alterations due to low dose docetaxel via metronomic schedule.
Acronym
A retrospective analysis of nail alterations due to low dose docetaxel via metronomic schedule.
Scientific Title
A retrospective analysis of nail alterations due to low dose docetaxel via metronomic schedule.
Scientific Title:Acronym
A retrospective analysis of nail alterations due to low dose docetaxel via metronomic schedule.
Region
| Japan |
Condition
Condition
Non Small Cell Lung Cancer
Classification by specialty
| Pneumology | Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the nail alterations due to low dose metronomic docetaxel chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Degree and prevalence of nail alterations.
Key secondary outcomes
Predictive factor for nail alterations.
Contribution of nail alterations for survival.
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
Histologicaly or cytologicaly diagnosed NSCLC.
Patients of NSCLC who were treated with low dose metronomic docetaxel at Kansai Medical University Takii Hospital from January 1999 to December 2010.
Key exclusion criteria
Patients who lack adequate medical record for nail alterations.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Shimizu |
Organization
Kansai Medical University
Division name
1st department of internal medicine
Zip code
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL
06-6992-1001
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiki Shimizu |
Organization
Kansai Medical University
Division name
1st department of internal medicine
Zip code
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL
Homepage URL
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
| 2012 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.spandidos-publications.com/ol/5/4/1123
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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the nail alterations due to low dose metronomic docetaxel treatment.
Management information
Registered date
| 2012 | Year | 09 | Month | 11 | Day |
Last modified on
| 2013 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010440
