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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040415
Receipt No. 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 2020/05/15

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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 Koichi
Middle name
Last name Hagiwara
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
Email hagiwark@jichi.ac.jp

Public contact
Name of contact person
1st name Chika
Middle name
Last name Suga
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
Email nejsg-dm@nejsg.jp

Sponsor
Institute Jichi Medical University
Institute
Department

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
Email shien@jichi.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
2020 Year 05 Month 20 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 02 Month 07 Day
Date of IRB
2020 Year 03 Month 26 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2021 Year 11 Month 30 Day
Date of closure to data entry
2021 Year 11 Month 30 Day
Date trial data considered complete
2021 Year 11 Month 30 Day
Date analysis concluded
2021 Year 11 Month 30 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
2020 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046120

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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