UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040415 |
|---|---|
| Receipt number | R000046120 |
| Scientific Title | Screening of draggable mutations in cytological samples obtained from lung cancer patients using a highly sensitive, multigene test, MINtS |
| Date of disclosure of the study information | 2020/05/20 |
| Last modified on | 2025/05/22 17:01:28 |
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Basic information
Public title
Screening of draggable mutations in cytological samples obtained from lung cancer patients using a highly sensitive, multigene test, MINtS
Acronym
Screening of draggable mutations in cytological samples obtained from lung cancer patients using a highly sensitive, multigene test, MINtS
Scientific Title
Screening of draggable mutations in cytological samples obtained from lung cancer patients using a highly sensitive, multigene test, MINtS
Scientific Title:Acronym
Screening of draggable mutations in cytological samples obtained from lung cancer patients using a highly sensitive, multigene test, MINtS
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Target: Patient who are suspected of having lung cancer or who are suspected of having an exacerbating or relapsed disease by imaging studies.
Samples: cytological samples
MINtS (Mutation Investigator using the Next-era Sequencer): a mutation test that can detect multiple druggable mutations from cytological samples in one assay.
Purpose: (1) Investigate the clinical utility of MINtS by examining the concordance of the results obtained by companion diagnostics already approved in Japan; where MINtS uses cytological samples and the companion diagnositics uses tissue samples concomitantly obtained from the same patients.
(2) Investigate the economical superiority of MINtS over the approved companion diagnostics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The detection rate of draggable mutations from cytological samples when the concomitantly isolated tissue samples contain cancer cells.
Key secondary outcomes
(1) The rate that amenable DNA is isolated.
(2) The rate that amenable RNA is isolated.
(3) The rate that MINtS is successfully performed.
(4) The number of patients who are positive for cancer in cytological samples and positive for cancer in tissue samples.
(5) The number of patients who are negative for cancer in cytological samples and positive for cancer in tissue samples.
(6) The number of patients who are positive for cancer in cytological samples and negative for cancer in tissue samples.
(7) Detection rate of draggable mutations in patients who are positive for cancer in cytological samples and positive for cancer in tissue samples.
(8) Detection rate of draggable mutations in patients who are negative for cancer in cytological samples and positive for cancer in tissue samples.
(9) Detection rate of draggable mutations in patients who are positive for cancer in cytological samples and negative for cancer in tissue samples.
(10) The rate that the sample is submitted to the companion diagnostics already approved in Japan when tissue sample is positive for cancer cells.
(11) The concordance rate between MINtS and the companion diagnostics already approved in Japan when when the samples is positive for both cytological samples and tissue samples.
(12) The difference of prices between MINtS and the companion diagnostics already approved in Japan when when the samples is positive for both cytological samples and tissue samples.
(13) The overall response rate defined by the doctor in charge in patients who are positive for draggable mutations detected either by the companion diagnostics already approved in Japan or by MINtS.
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) Patients who are equal to or more than 20 years old when the informed consent is obtained.
2) Patient who are suspected of having lung cancer or who are suspected of having an exacerbating or relapsed disease by imaging studies.
3) Patients from whom both cytological and tissue samples are obtained and cancer cells are detected in either cytological sample or tissue sample.
4) Patients from whom informed consent is obtained.
Key exclusion criteria
Pattens who do not fulfill the inclusion criteria.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Nakayama |
Organization
Jichi Medical University
Division name
Division of Pulmonary Medicine, Department of Internal Medicine
Zip code
329-0431
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken
TEL
0285-58-7349
mnakayama723@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Yamasaki |
Organization
Non-profit organization North East Japan Study Group
Division name
Office
Zip code
330-0843
Address
2nd Floor, One-light Building 1-133-1 Yoshiki-machi, Oomiya-ku, Saitama-shi, Saitama-ken
TEL
048-778-9521
Homepage URL
nejsg-dm@nejsg.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
EIKEN CHEMICAL CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Clinical Research Ethics Committee
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
Tel
0285-58-7637
shien@jichi.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NEJ021C
Org. issuing International ID_1
Non-profit organization North East Japan Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
JCHO 北海道病院（北海道）、北海道大学病院（北海道）、青森県立中央病院（青森県）、岩手医科大学附属病院（岩手県）、仙台厚生病院（宮城県）、東北大学病院（宮城県）、宮城県立がんセンター（宮城県）、獨協医科大学病院（栃木県）、自治医科大学附属病院（栃木県）、済生会宇都宮病院（栃木県）、群馬大学医学部附属病院（群馬県）、埼玉医科大学国際医療センター（埼玉県）、自治医科大学附属さいたま医療センター（埼玉県）、聖路加国際病院（東京都）、日本医科大学付属病院（東京都）、順天堂大学医学部附属順天堂医院（東京都）、東京大学医学部附属病院（東京都）、新潟大学医歯学総合病院（新潟県）、島根大学医学部附属病院（島根県）、県立広島病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1536
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
| 2020 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
Primary endpoint
The detection rate of draggable mutations from cytological samples when the concomitantly isolated tissue samples contain cancer cells.
Secondary endpoints
(1) The rate that amenable DNA is isolated.
(2) The rate that amenable RNA is isolated.
(3) The rate that MINtS is successfully performed.
(4) The number of patients who are positive for cancer in cytological samples and positive for cancer in tissue samples.
(5) The number of patients who are negative for cancer in cytological samples and positive for cancer in tissue samples.
(6) The number of patients who are positive for cancer in cytological samples and negative for cancer in tissue samples.
(7) Detection rate of draggable mutations in patients who are positive for cancer in cytological samples and positive for cancer in tissue samples.
(8) Detection rate of draggable mutations in patients who are negative for cancer in cytological samples and positive for cancer in tissue samples.
(9) Detection rate of draggable mutations in patients who are positive for cancer in cytological samples and negative for cancer in tissue samples.
(10) The rate that the sample is submitted to the companion diagnostics already approved in Japan when tissue sample is positive for cancer cells.
(11) The concordance rate between MINtS and the companion diagnostics already approved in Japan when when the samples is positive for both cytological samples and tissue samples.
(12) The difference of prices between MINtS and the companion diagnostics already approved in Japan when when the samples is positive for both cytological samples and tissue samples.
(13) The overall response rate defined by the doctor in charge in patients who are positive for draggable mutations detected either by the companion diagnostics already approved in Japan or by MINtS.
Management information
Registered date
| 2020 | Year | 05 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046120
