UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012552 |
|---|---|
| Receipt number | R000014688 |
| Scientific Title | An Observational Screening Study of Overexpression/Amplification/Mutation of HER2 and its Related Molecules in Non-Small Cell Lung Cancer Patients for Personalized Medicine with Trastuzumab (HER2-CLHERC-A/HOT1303-A) |
| Date of disclosure of the study information | 2013/12/11 |
| Last modified on | 2017/05/11 23:20:57 |
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Basic information
Public title
An Observational Screening Study of Overexpression/Amplification/Mutation of HER2 and its Related Molecules in Non-Small Cell Lung Cancer Patients for Personalized Medicine with Trastuzumab (HER2-CLHERC-A/HOT1303-A)
Acronym
An Observational Study of Abnormalities of HER2 and its Related Molecules in Non-Small Cell Lung Cancers (HER2-CLHERC-A/HOT1303-A)
Scientific Title
An Observational Screening Study of Overexpression/Amplification/Mutation of HER2 and its Related Molecules in Non-Small Cell Lung Cancer Patients for Personalized Medicine with Trastuzumab (HER2-CLHERC-A/HOT1303-A)
Scientific Title:Acronym
An Observational Study of Abnormalities of HER2 and its Related Molecules in Non-Small Cell Lung Cancers (HER2-CLHERC-A/HOT1303-A)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine overexpression/amplification/mutation of HER2 and its related molecules including driver genes in non-small cell lung cancer, identify patients potentially eligible for trastuzumab therapy, and characterize their clinicopathological and molecular biological features.
Basic objectives2
Others
Basic objectives -Others
To determine biological and clinical significance of abnormalities of HER2 and its related molecules in non-small cell lung cancer.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of overexpression, amplification and mutation of HER2 in non-small cell lung cancer
Key secondary outcomes
1) Frequency of overexpression, amplification and mutation of HER2 related molecules including driver genes in non-small cell lung cancer
2) Correlation between HER2 and its related molecules
3) Correlation between their abnormalities and clinical and clincopathological features
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) Patients aged 20 years and over at the time of consent
2) Histologically confirmed diagnosis of non-small cell lung cancer
3) EGFR mutation negative
4) Patients who meets either of the following criteria:
i) unresectable locally advanced or metastatic disease
ii) post-operative recurrent disease
iii) progressive disease after radical radiation therapy
5) Patients who plan to receive first line chemotherapy or who undergo or complete first or subsequent lines of chemotherapy
6) Formalin-fixed paraffin embedded (FFPE) samples containing NSCLC tissue are available
7) Written informed consent
Key exclusion criteria
Alk fusion-positive patients who underwent ALK testing. (Patients who have not undergone ALK testing are eligible.)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Akita |
Organization
Hokkaido University Hospital
Division name
Department of Medical Oncology
Zip code
Address
North 14, West 5, Kita-ku, Sapporo, 060-8648 Japan
TEL
011-706-5551
hdakita@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Kinoshita |
Organization
Hokkaido University Hospital
Division name
Department of Medical Oncology
Zip code
Address
North 14, West 5, Kita-ku, Sapporo, 060-8648 Japan
TEL
011-706-5551
Homepage URL
kinoshii@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Lung Cancer Clinical Study Group
Institute
Department
Personal name
Funding Source
Organization
Clinical Trials Core Hospitals Project
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2013 | Year | 12 | Month | 11 | 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
| 2013 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study.
Management information
Registered date
| 2013 | Year | 12 | Month | 11 | Day |
Last modified on
| 2017 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014688
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| Registered date | File name |
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