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

Adenocarcinoma of Lung Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02946216
• Other study ID #: 2016-101-01
• Status: Not yet recruiting
• Phase: N/A
• First received: October 25, 2016
• Last updated: October 25, 2016
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: October 2016
• Source: First People's Hospital of Hangzhou
• Contact: Shenglin Ma, M.D
• Phone: 057156007908
• Email: mashenglin[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Genetic:
• ctDNA analysis

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital, Nanjing Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART)	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)	up to 2 years	No
Primary	Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART) after crizotinib resistance	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	up to 2 years	No