UMIN-CTR Clinical Trial

Basic information
Public title	Less Invasive Monitoring of Resistance Mutations in Patients with ALK Rearranged Lung Cancer
Acronym	Liquid Biopsy for ALK rearranged NSCLC
Scientific Title	Less Invasive Monitoring of Resistance Mutations in Patients with ALK Rearranged Lung Cancer
Scientific Title:Acronym	Liquid Biopsy for ALK rearranged NSCLC
Region	Japan

Condition
Condition	ALK rearranged NSCLC
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The strategy for early intervention to avoid clinical disease progression is not studied. In this study, we will assess Clinical Feasibility of Serial quantitative monitoring of ALK acquired mutation from plasma using high sensitive and high specific digital PCR method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To determine duration between clinical PD and emergence of ALK resistant mutations
Key secondary outcomes	Concordance of ALK resistant mutations between tissue and plasma using ddPCR Concordance of ALK resistant mutations between plasma detected by ddPCR and re-biopsy tissue detected by NGS based assay at disease progression

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	Age 20 year or older patients newly diagnosed with ALK+ NSCLC confirmed by tissue biopsy and going to receive ALK-TKIs patients already diagnosed with ALK+ NSCLC and have received ALK-TKIs
Key exclusion criteria	patients who have more than one type of carcinoma patients who reject to sign the informed consent from
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Takaaki Middle name Last name Sasaki
Organization	Asahikawa Medical University
Division name	Respiratory Center
Zip code	078-8510
Address	Midorigaoka-Higashi 2-1-1-1
TEL	0166693290
Email	takaaki6@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Takaaki Middle name Last name Sasaki
Organization	Asahikawa Medical University
Division name	Respiratory Center
Zip code	0788510
Address	Midorigaoka-Higashi 2-1-1-1
TEL	0166-69-3290
Homepage URL
Email	takaaki6@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	INVESTIGATOR-INITIATED RESEARCH/Pfizer
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Asahikawa Medical University Research Ethics Committee
Address	Midorigaoka-Higashi 2-1-1-1
Tel	0166-68-2297
Email	rs-kk.g@asahikawa-med.ac.jp

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	2018 Year 05 Month 22 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	Completed
Date of protocol fixation	2017 Year 12 Month 05 Day
Date of IRB	2017 Year 12 Month 05 Day
Anticipated trial start date	2018 Year 01 Month 05 Day
Last follow-up date	2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 11 Month 30 Day
Date analysis concluded	2022 Year 05 Month 01 Day

Other
Other related information	Liquid Biopsy for ALK resistance mutation using ddPCR

Management information
Registered date	2018 Year 05 Month 22 Day
Last modified on	2022 Year 08 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037260