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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041237
Receipt No. R000047089
Scientific Title A Prospective Observational Study on the Efficacy of detecting circulating tumor DNA by Means of a Next-Generation Sequencer Using Cell-Free DNA in lung cancer patients
Date of disclosure of the study information 2020/07/28
Last modified on 2020/07/28

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Basic information
Public title A Prospective Observational Study on the Efficacy of detecting circulating tumor DNA by Means of a Next-Generation Sequencer Using Cell-Free DNA in lung cancer patients
Acronym cfDNA analysis in lung cancer patients
Scientific Title A Prospective Observational Study on the Efficacy of detecting circulating tumor DNA by Means of a Next-Generation Sequencer Using Cell-Free DNA in lung cancer patients
Scientific Title:Acronym cfDNA analysis in lung cancer patients
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this research is to verify the effectiveness of molecular staging detecting circulating tumor DNA analysis by means of a next-generation sequencer using cell free DNA (cfDNA) derived from lung cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The purpose of this research is to verify the effectiveness of detecting circulating tumor DNA analysis by means of a next-generation sequencer using cell free DNA (cfDNA) derived from lung cancer patients and to verify the relation to the postoperative recurrence.
Key secondary outcomes

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. Non-small cell lung cancer patients clinical stage IB-IVA.
2. 20 years old or above
3. With written informed consent.
Key exclusion criteria 1. Positive for infection (HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody)
2. Cases in which the principal investigator determined that the subject was inappropriate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Yoshino
Organization Graduate School of Medicine,Chiba University
Division name Department of General Thoracic Surgery
Zip code 2608670
Address 1-8-1 Inohana, chuo-ku, Chiba, Japan
TEL 043-222-7171
Email iyoshino@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Kazuhisa
Middle name
Last name Tanaka
Organization Graduate School of Medicine,Chiba University
Division name Department of General Thoracic Surgery
Zip code 2608670
Address 1-8-1 Inohana, chuo-ku, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email kaztanaka-ths@umin.ac.jp

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Chiba University Hospital Clinical Research Center
Address 1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN
Tel 043-226-2734
Email chibacrc@mac.com

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
2020 Year 07 Month 28 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 25 Day
Date of IRB
2020 Year 06 Month 26 Day
Anticipated trial start date
2020 Year 06 Month 26 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2020 Year 07 Month 28 Day
Last modified on
2020 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047089

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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