ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC

Sponsor

First People's Hospital of Hangzhou (Other)

Overall Status

Unknown status

CT.gov ID

NCT02946216

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA samples in EGFR-wildtype NSCLC

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer Stage III Non-Small-Cell Lung Cancer Metastatic Adenocarcinoma of Lung EGFR Wildtype	Genetic: ctDNA analysis

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Frequency and Abundance of ALK/ROS1/MET Mutations on Circulating Tumor DNA in Patients With Non-small Cell Lung Cancer Using Single Molecule Amplifcation and Re-sequencing Technology: a Perspective Observational Study

Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2017

Anticipated Study Completion Date :

Nov 1, 2018

Outcome Measures

Primary Outcome Measures

Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART) [up to 2 years]
The investigators will describe the proportion of ALK/ROS1/MET mutations on ctDNA detected by cSMART in patients with non-small cell lung cancer (NSCLC)
Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART) after crizotinib resistance [up to 2 years]
The investigators will describe the proportion of ALK/ROS1/MET mutations on ctDNA detected by cSMART in patients with non-small cell lung cancer (NSCLC) after crizotinib resistance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed stage IIIB/IV NSCLC;
Histologically confirmed adenocarcinoma;
EGFR-wildtype NSCLC;
Provision of blood (plasma) sample for ctDNA testing;
Patient must be able to comply with the protocol;
Provision of blood (plasma) sample for ctDNA testing;

Exclusion Criteria:

As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
Histologically confirmed small cell lung cancer or other metastatic tumors;
Patient with no histologic or cytological diagnosis;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hangzhou First People's Hospital, Nanjing Medical University	Hangzhou	Zhejiang	China	310006

Sponsors and Collaborators

First People's Hospital of Hangzhou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First People's Hospital of Hangzhou

ClinicalTrials.gov Identifier:

NCT02946216

Other Study ID Numbers:

2016-101-01

First Posted:

Oct 27, 2016

Last Update Posted:

Oct 27, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Adenocarcinoma of Lung

Study Results

No Results Posted as of Oct 27, 2016