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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032676
Receipt No. R000037260
Scientific Title Less Invasive Monitoring of Resistance Mutations in Patients with ALK Rearranged Lung Cancer
Date of disclosure of the study information 2018/05/22
Last modified on 2018/05/22

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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
Middle name
Last name Takaaki Sasaki
Organization Asahikawa Medical University
Division name Respiratory Center
Zip code
Address Midorigaoka-Higashi 2-1-1-1
TEL 0166-69-3290
Email takaaki6@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaaki Sasaki
Organization Asahikawa Medical University
Division name Respiratory Center
Zip code
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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2018 Year 05 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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