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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02946216

Enrollment

200

Registered

2016-10-27

Start date

2016-11-30

Completion date

2018-11-30

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer Stage III, Non-Small-Cell Lung Cancer Metastatic, Adenocarcinoma of Lung, EGFR Wildtype

Brief summary

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

Interventions

GENETICctDNA analysis

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactShenglin Ma, M.D

mashenglin@medmail.com.cn057156007908

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026