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 2022/05/19 11:11:03

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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 Chinatsu
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 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

Email

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

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

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

2023 Year 07 Month 31 Day

Date of closure to data entry

2023 Year 10 Month 31 Day

Date trial data considered complete

2023 Year 12 Month 31 Day

Date analysis concluded

2023 Year 12 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

2022 Year 05 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046120


Research Plan
Registered date File name
2021/06/11 NEJ021C_実施計画書_v.1.2.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name