UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041237 |
|---|---|
| Receipt number | 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 | 2024/02/02 11:25:15 |
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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
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
kaztanaka-ths@umin.ac.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
15
Results
15 patients were enrolled in this study.
We are observing their postoperative course.
We have begun analyzing specimens mainly from recurrent cases.
Results date posted
| 2022 | Year | 02 | Month | 28 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
There were few recurrences.
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
No longer recruiting
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
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 06 | Month | 30 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 07 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047089
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
