UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study for correlation between disease progression and detection of T790M in plasma DNA using MBP-QP method in non-small cell lung cancer patients treated with EGFR tyrosine kinase inhibitors
Title of the study (Brief title)	Prospective study for correlation between disease progression and T790M detection in plasma DNA in non-small cell lung cancer (HASAT study)
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this prospective study is to determine whether disease progression and detection of T790M in plasma DNA are correlated in non-small lung cancer patients. This is observational study.
Basic objectives2	Others
Basic objectives -Others	The study is to determine the usefulness of T790M detection using the assay system.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The population of patients with presence of T790M in plasma DNA among those who acquired resistance to EGFR-TKI is calculated.
Key secondary outcomes	The concordance of T790M in plasma DNA and those in cancer tissues or effusions are evaluated. The serial analysis of T790M in plasma DNA and anti-tumor effect of EGFR-TKI are also examined.

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	1. Non-small cell lung cancer patients with EGFR activating mutations such as exon 19 deletion and L858R. 2. Non-small cell lung cancer patients with lesions which can be evaluated by RECIST (Version 1.1). 3. Non-small cell lung cancer patients with written consent.
Key exclusion criteria	1. Non-small cell lung cancer patients with EGFR mutations which is related with acquired resistance such as T790M. 2. Non-small cell lung cancer patients who is not appropriated for the study determined by physician in charge.
Target sample size	80

Research contact person
Name of lead principal investigator	Shunichi Negoro, Shinya Kimura
Organization	Hyogo Cancer Center, Saga Univ, Faculty of Medicine
Division name	Dept. of Medical Oncology,
Address	13-70, Kitaoji-cyo, Akashi, Hyogo, 673-8558
TEL
Email

Public contact
Name of contact person	Naoko Aragane
Organization	Hanshin-Saga Collaborative Cancer Study Group
Division name	Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga Univ.
Address	5-1-1 Nabeshima, Saga, 849-8501
TEL	0952-34-2369
Homepage URL
Email	sueokan@cc.saga-u.ac.jp

Sponsor
Institute	Foundation for Biomedical Research and Innovation
Institute
Department

Funding Source
Organization	Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization	Non profit foundation
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	兵庫県立がんセンター（兵庫県）Hyogo Cancer Center 先端医療センター（兵庫県）Foundation for Biomedical Research and Innovation 神戸大学医学部（兵庫県）Kobe Univ. Graduate School of Medicine 刀根山病院（大阪府）Toneyama National Hospital 佐賀県立病院好生館（佐賀県）Saga Prefectural Hospital Koseikan 佐賀大学医学部（佐賀県）Faculty of Medicine, Saga Univ. 山口宇部医療センター（山口県）National Hospital Organization Yamaguchi-Ube Medical Center

Other administrative information
Date of disclosure of the study information	2011 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 10 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2014 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://doi.org/10.1111/cas.12847
Results
Other related information	The population of patients with presence of T790M in plasma DNA among those who acquired resistance to EGFR-TKI is calculated. The concordance of T790M in plasma DNA and those in cancer tissues or effusions are evaluated. The serial analysis of T790M in plasma DNA and anti-tumor effect of EGFR-TKI are also examined.

Management information
Registered date	2011 Year 02 Month 24 Day
Last modified on	2019 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006091