UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022311
Receipt number R000025129
Scientific Title Clinical performance study of a lung fusion kit
Date of disclosure of the study information 2016/05/23
Last modified on 2019/10/29 15:53:15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Clinical performance study of a lung fusion kit

Acronym

Clinical performance study of a lung fusion kit

Scientific Title

Clinical performance study of a lung fusion kit

Scientific Title:Acronym

Clinical performance study of a lung fusion kit

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of a lung fusion kit for diagnostic performance in fusion positive NSCLC

Basic objectives2

Others

Basic objectives -Others

Evaluation of a lung fusion kit for diagnostic performance

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To compare the clinical performance of a lung fusion kit for ALK fusion diagnosis with that of a conventional IVD kit.
Sensitivity, specificity, and concordance in the detection of ALK gene fusions using a lung fusion kit.

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients diagnosed with NSCLC
2) Formalin-fixed paraffin embedded tissues archived for a period less than 2 years

Key exclusion criteria

1) Formalin fixed paraffin embedded tissues archived for a period longer than two years
2) Patients diagnosed with EGFR mutation-positive NSCLC
3) Patients who are judged inappropriate to be enrolled in this study.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nishio Kazuto

Organization

Kindai University Faculty of Medicine

Division name

Department of Genome Biology

Zip code


Address

377-2 Ohno-Higashi Osaka-Sayama, Osaka

TEL

072-366-0221

Email

knishio@med.kindai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sakai Kazuko

Organization

Kindai University Faculty of Medicine

Division name

Department of Genome Biology

Zip code


Address

377-2 Ohno-Higashi Osaka-Sayama, Osaka

TEL

072-366-0221

Homepage URL


Email

kasakai@med.kindai.ac.jp


Sponsor or person

Institute

Department of Genome Biology, Kindai University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Life Technologies Japan Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tokyo Medical University

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 05 Month 23 Day


Related information

URL releasing protocol

none

Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/full/10.1111/cas.14016

Number of participants that the trial has enrolled

150

Results

We used FFPE tissue samples of NSCLC from 150 EGFR mutation-negative cases and compared the performance of the Oncomine Dx Fusion Transcript Test (ODxFT) with FISH break-apart for the detection of ALK, RET, and ROS1 fusion genes. Concordance rate between the ODxFT and ALK-FISH analyses was 99.3%. Sensitivity and specificity were 91.7% and 99.3%, respectively. ODxFT was thus validated as an effective method for detecting clinically significant ALK fusion genes in FFPE tissue samples.

Results date posted

2019 Year 10 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Non-small cell lung cancer

Participant flow

None

Adverse events

None

Outcome measures

Rate of fusion genes

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 02 Month 15 Day

Date of IRB

2016 Year 03 Month 31 Day

Anticipated trial start date

2016 Year 05 Month 23 Day

Last follow-up date

2017 Year 04 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients who were diagnosed with NSCLC at Kinki University Hospital and Tokyo Medical University Hospital and who satisfied predetermined criteria for the study.
Detection of a lung fusion genes (ALK, RET, ROS1, and NTRK1) using formalin-fixed paraffin embedded tissues.


Management information

Registered date

2016 Year 05 Month 14 Day

Last modified on

2019 Year 10 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025129


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name