UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Hirotoshi Akita
Organization	Hokkaido University Hospital
Division name	Department of Medical Oncology
Address	North 14, West 5, Kita-ku, Sapporo, 060-8648 Japan
TEL	011-706-5551
Email	hdakita@med.hokudai.ac.jp

Public contact
Name of contact person	Ichiro Kinoshita
Organization	Hokkaido University Hospital
Division name	Department of Medical Oncology
Address	North 14, West 5, Kita-ku, Sapporo, 060-8648 Japan
TEL	011-706-5551
Homepage URL
Email	kinoshii@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido Lung Cancer Clinical Study Group
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 10 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014688