UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037133
Receipt number R000042320
Scientific Title Detecting low allele frequency of compound minor mutation using high-sensitivity next generation sequencer for EGFR mutant lung cancer
Date of disclosure of the study information 2019/06/21
Last modified on 2019/06/21 21:19:32

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Basic information

Public title

Detecting low allele frequency of compound minor mutation using high-sensitivity next generation sequencer for EGFR mutant lung cancer

Acronym

Detecting compound minor mutation using NGS for EGFR mutant lung cancer

Scientific Title

Detecting low allele frequency of compound minor mutation using high-sensitivity next generation sequencer for EGFR mutant lung cancer

Scientific Title:Acronym

Detecting compound minor mutation using NGS for EGFR mutant lung cancer

Region

Japan


Condition

Condition

EGFR-mutant lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The aim of this study is to prospectively investigate detecting rate of EGFR compound minor mutation containing Ex20 T790M using high-sensitivity NGS at diagnostic phase and re-biopsy phase to compare the subsequence genetic change.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Detection rate of EGFR compound minor mutation using NGS

Key secondary outcomes

1) Allele frequency of sensitive mutation and compound minor mutation, and its corelation for response rate and PFS.
2) T790M detection rate at diagnostic phase and re-biopsy phase
3) Subsequent allele frequency change of EGFR compound minor mutation


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) EGFR-mutant lung cancer
2) Written informed consent

Key exclusion criteria

Other cases attending physician it is determined unsuitable for registration of the study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Kei
Middle name
Last name Morikawa

Organization

St. Marianna University School of Medicine

Division name

Division of Respiratory Diseases, Department of Internal Medicine

Zip code

216-8511

Address

2-16-1 Sugao Miyamae-ku, Kawasaki

TEL

044-977-8111

Email

mokke5454@yahoo.co.jp


Public contact

Name of contact person

1st name Kei
Middle name
Last name Morikawa

Organization

St. Marianna University School of Medicine

Division name

Division of Respiratory Diseases, Department of Internal Medicine

Zip code

216-8511

Address

2-16-1 Sugao Miyamae-ku, Kawasaki

TEL

044-977-8111

Homepage URL


Email

mokke5454@yahoo.co.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Boehringer Ingelheim GmbH

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

St. Marianna University School of Medicine

Address

2-16-1 Sugao Miyamae-ku, Kawasaki

Tel

044-977-8111

Email

mokke5454@yahoo.co.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

#4395

Org. issuing International ID_1

St. Marianna University School of Medicine

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

聖マリアンナ医科大学


Other administrative information

Date of disclosure of the study information

2019 Year 06 Month 21 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

2019 Year 05 Month 01 Day

Date of IRB

2019 Year 06 Month 13 Day

Anticipated trial start date

2019 Year 06 Month 21 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

ongoing


Management information

Registered date

2019 Year 06 Month 21 Day

Last modified on

2019 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042320


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name