UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019446 |
|---|---|
| Receipt number | R000022480 |
| Scientific Title | A study of biomarkers that predict efficacy of or resistance to trastuzumab emtansine for patients with HER2-positive non-small cell lung cancer |
| Date of disclosure of the study information | 2015/10/21 |
| Last modified on | 2015/10/21 22:00:20 |
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Basic information
Public title
A study of biomarkers that predict efficacy of or resistance to trastuzumab emtansine for patients with HER2-positive non-small cell lung cancer
Acronym
Biomarker study of T-DM1 for HER2-positive non-small cell lung cancer
Scientific Title
A study of biomarkers that predict efficacy of or resistance to trastuzumab emtansine for patients with HER2-positive non-small cell lung cancer
Scientific Title:Acronym
Biomarker study of T-DM1 for HER2-positive non-small cell lung cancer
Region
| Japan |
Condition
Condition
HER2-positive, recurrent, non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore potential biomarkers related to efficacy of or resistance to T-DM1 for patients with HER2-positive non-small cell lung cancer
Basic objectives2
Others
Basic objectives -Others
Biomarker study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Identification of biomarkers related to efficacy of or resistance to T-DM1 for patients with HER2-positive non-small cell lung cancer
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Enrolled on a study of trastuzumab emtansine in patients with HER2-positive recurrent metastatic non-small cell lung cancer (HER2-CS-2 study)
(2)Written informed consent
Key exclusion criteria
There are no special instruction regarding this section.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Kiura |
Organization
Okayama University Hospital
Division name
Allergy and respiratory medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-Ku,Okayama
TEL
086-235-7227
kkiura@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroe Kayatani |
Organization
Okayama University Hospital
Division name
Allergy and respiratory medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-Ku,Okayama
TEL
086-235-7227
Homepage URL
hk64hk85@yahoo.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Allergy and respiratory medicine, Okayama University 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 | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will evaluate several protein levels in serum and cancer-related genes within the tumor tissue from patients with HER2 positive non-small cell lung cancer who enrolled in HER2-CS-2 study, and will explore potential biomarkers related to efficacy of or resistance to T-DM1.
Management information
Registered date
| 2015 | Year | 10 | Month | 21 | Day |
Last modified on
| 2015 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022480
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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