UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026695 |
|---|---|
| Receipt number | R000030358 |
| Scientific Title | Measurement of saliva drug concentration in patients undergoing cancer chemotherapy |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2020/04/01 10:52:28 |
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Basic information
Public title
Measurement of saliva drug concentration in patients undergoing cancer chemotherapy
Acronym
Measurement of saliva drug concentration in patients undergoing cancer chemotherapy
Scientific Title
Measurement of saliva drug concentration in patients undergoing cancer chemotherapy
Scientific Title:Acronym
Measurement of saliva drug concentration in patients undergoing cancer chemotherapy
Region
| Japan |
Condition
Condition
Gastrointestinal malignant tumor, Breast cancer
Classification by specialty
| Gastrointestinal surgery | Breast surgery | Obstetrics and Gynecology |
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
I investigate the influence of the presence of the drug shift in the oral cavity of the anticancer agent and the side effect appearance by measuring the drug level out of saliva of the cancer chemotherapy enforced patient about a side effect of use of anticancer agent appearance of oral mucositis and the taste disorder qualitatively and quantitatively .
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At the time of the intravenous feeding dosage end of the anticancer agent, We collect saliva seven days later for 72 hours for 24 hours. We measure the drug blood concentration of saliva which we collected qualitatively and quantitatively using liquid chromatograph - tandem type mass spectrometer (LC/MS/MS).
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Adequate organ functiont
2.Psrformance status:0-2
3.Written informed consent prior to sutudy-spe cific screening procedure
Key exclusion criteria
Cannot collect saliva by oneself.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Sano |
Organization
Saitama Medical Center Saitama Medical University
Division name
department of pharmacy
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3599
msano@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Motohiko |
| Middle name | |
| Last name | Sano |
Organization
Saitama Medical Center Saitama Medical University
Division name
department of pharmacy
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3599
Homepage URL
msano@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center Saitama 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
Saitama Medical Center Saitama Medical University
Address
1981 Kamoda, Kawagoe, Saitama
Tel
049-228-3400
irbsmc@saitama-med.ac.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
| 2017 | Year | 03 | Month | 30 | 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
6
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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 03 | Month | 25 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030358
