臨床研究等提出・公開システム

Date of registration	July. 20, 2023
Last modified on	Oct. 17, 2023
Trial ID	jRCT1030230246

Scientific Title	Retrospective analysis of patient flow in NSCLC with delayed detection of druggable mutation using C-CAT database (C-CAT data base study in NSCLC patients)
Public Title	Retrospective analysis of patient flow in NSCLC with delayed detection of druggable mutation using C-CAT database (C-CAT data base study in NSCLC patients)

Contact for Scientific Queries	Name	Yokochi Yuya
	Affiliation	Novartis Pharma K.K.
	Address	Toranomon Hills, Mori Tower1-23-1, Toranomon Minato-ku Tokyo 105-6333
	Telephone	+81-120003293
	E-mail	imi.medica.mee.csmap@novartis.com
Contact for Public Queries	Name	Novartis Direct
	Affiliation	Novartis Pharma K.K.
	Address	Toranomon Hills, Mori Tower1-23-1, Toranomon Minato-ku Tokyo 105-6333
	Telephone	+81-120003293
	E-mail	imi.medica.mee.csmap@novartis.com

Recruitment status	Recruiting


Anticipated date of first enrollment		July. 20, 2023
Target sample size		1314
Study Type		Other
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Adult (aged 15 years or more) patients with histologically or cytologically confirmed NSCLC
	Exclusion Criteria	1. Patients who have already been confirmed to have a drug-treatable mutation/translocation by the end of standard therapy 2. Patients who received targeted therapy against driver genes before finishing standard therapy
	Age Minimum	15age 0month 0week old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		NSCLC
Health Condition(s) Keyword		NSCLC, C-CAT, driver gene
Health Condition(s) Code		D002289
Primary Outcome(s)		Among patients with NSCLC diagnosed with wild type (WT) who have completed (or are expected to complete) standard therapy and who underwent comprehensive genomic profiling (CGP) testing, the proportion of patients diagnosed with a drug-treatable mutation by CGP testing ratio Among patients with NSCLC diagnosed with WT who have completed (or are expected to complete) standard therapy and who underwent comprehensive genomic profiling (CGP) testing, the proportion of patients diagnosed with a drug-treatable mutation by CGP testing , percentage by year
Secondary Outcome(s)		Describe the characteristics of NSCLC patients with delayed detection of drug-treatable genetic mutations Describe the degree of delay in NSCLC patients with delayed detection of drug-treatable genetic mutations Describe treatment patterns for NSCLC patients with delayed detection of drug-treatable genetic mutations Describe the frequency of delayed detection of drug-treatable genetic mutations by site type Patient baseline characteristics (gender, age, family history, etc.) Time from start of first-line therapy to detection of a drug-treatable mutation Treatment patterns for NSCLC patients with drug-treatable mutations Number and proportion of regimens in each line of treatment Duration of each line of therapy Percentage of patients diagnosed with a drug-treatable mutation by CGP testing, by facility type (size, academic/community, etc.)

Primary Sponsor	Novartis Pharma K.K.

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Kitamachi clinic
Address	Kitamachi1-1-3, Kichijoji, Musashino-shi, Tokyo
Telephone	+81-3-6779-8166
E-Mail	chi-pr-ec-kitamachi@cmicgroup.com
Approval Status	Approval
Date of approval	May. 24, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 17, 2023	(this page)	Changes
1	July. 20, 2023	Detail

List of change history