UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019484 |
|---|---|
| Receipt number | R000022528 |
| Scientific Title | Analysis of therapeutic response onset time in thyroid cancer patients treated by lenvatinib |
| Date of disclosure of the study information | 2015/10/24 |
| Last modified on | 2015/10/24 00:08:19 |
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Basic information
Public title
Analysis of therapeutic response onset time in thyroid cancer patients treated by lenvatinib
Acronym
Analysis of therapeutic response onset time in thyroid cancer patients treated by lenvatinib
Scientific Title
Analysis of therapeutic response onset time in thyroid cancer patients treated by lenvatinib
Scientific Title:Acronym
Analysis of therapeutic response onset time in thyroid cancer patients treated by lenvatinib
Region
| Japan |
Condition
Condition
Thyroid cancer
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To figure out the onset time of therapeutic response in thyroid cancer patients treated by lenvatinib.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Characterization of tumor size changes of 2,4,6,8,12,16,20 and 24 weeks after medication.
Key secondary outcomes
Improved response rate, time to first objective response, efficacy, changes of CT imaging, association with thyroglobulin, clinical factors of good responders.
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
Thyroid cancer patients who treat by lenvatinib and can follow CT imagings regularly.
Key exclusion criteria
Thyroid cancer patients who treat by lenvatinib but can't follow CT imagings regularly.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chie Masaki |
Organization
Ito Hospital
Division name
Surgery
Zip code
Address
4-3-6, Jingumae, shibuya-ku, Tokyo, Japan, 150-8308
TEL
03-3402-7411
c-irikawa@ito-hospital.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie Masaki |
Organization
Ito Hospital
Division name
Surgery
Zip code
Address
4-3-6, Jingumae, shibuya-ku, Tokyo, Japan, 150-8308
TEL
03-3402-7411
Homepage URL
c-irikawa@ito-hospital.jp
Sponsor or person
Institute
Ito Hospital
Institute
Department
Personal name
Funding Source
Organization
Ito Hospital
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
| 2015 | Year | 10 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | 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
Make an evaluation of tumor size by CT imaging with RECIST ver 1.1 at 2,4,6,8,12,16,20 and 24 weeks after medication.
Management information
Registered date
| 2015 | Year | 10 | Month | 24 | Day |
Last modified on
| 2015 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022528
