UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032676
Receipt number R000037260
Scientific Title Less Invasive Monitoring of Resistance Mutations in Patients with ALK Rearranged Lung Cancer
Date of disclosure of the study information 2018/05/22
Last modified on 2022/08/03 10:46:08

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Basic information

Public title

Less Invasive Monitoring of Resistance Mutations in Patients
with ALK Rearranged Lung Cancer

Acronym

Liquid Biopsy for ALK rearranged NSCLC

Scientific Title

Less Invasive Monitoring of Resistance Mutations in Patients
with ALK Rearranged Lung Cancer

Scientific Title:Acronym

Liquid Biopsy for ALK rearranged NSCLC

Region

Japan


Condition

Condition

ALK rearranged NSCLC

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The strategy for early intervention to avoid clinical disease progression is not studied. In this study, we will assess Clinical Feasibility of Serial quantitative monitoring of ALK acquired mutation from plasma using high sensitive and high specific digital PCR method.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To determine duration between clinical PD and emergence of ALK resistant mutations

Key secondary outcomes

Concordance of ALK resistant mutations between tissue and plasma using ddPCR

Concordance of ALK resistant mutations between plasma detected by ddPCR and re-biopsy tissue detected by NGS based assay at disease progression


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

Age 20 year or older
patients newly diagnosed with ALK+ NSCLC confirmed by tissue biopsy and going to receive ALK-TKIs
patients already diagnosed with ALK+ NSCLC and have received ALK-TKIs

Key exclusion criteria

patients who have more than one type of carcinoma
patients who reject to sign the informed consent from

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Takaaki
Middle name
Last name Sasaki

Organization

Asahikawa Medical University

Division name

Respiratory Center

Zip code

078-8510

Address

Midorigaoka-Higashi 2-1-1-1

TEL

0166693290

Email

takaaki6@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name Takaaki
Middle name
Last name Sasaki

Organization

Asahikawa Medical University

Division name

Respiratory Center

Zip code

0788510

Address

Midorigaoka-Higashi 2-1-1-1

TEL

0166-69-3290

Homepage URL


Email

takaaki6@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



Funding Source

Organization

INVESTIGATOR-INITIATED RESEARCH/Pfizer

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Asahikawa Medical University Research Ethics Committee

Address

Midorigaoka-Higashi 2-1-1-1

Tel

0166-68-2297

Email

rs-kk.g@asahikawa-med.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

2018 Year 05 Month 22 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

Completed

Date of protocol fixation

2017 Year 12 Month 05 Day

Date of IRB

2017 Year 12 Month 05 Day

Anticipated trial start date

2018 Year 01 Month 05 Day

Last follow-up date

2020 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete

2020 Year 11 Month 30 Day

Date analysis concluded

2022 Year 05 Month 01 Day


Other

Other related information

Liquid Biopsy for ALK resistance mutation using ddPCR


Management information

Registered date

2018 Year 05 Month 22 Day

Last modified on

2022 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037260


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name