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

NCT02946216 | Unknown DMC

• 1 other identifier: 2016-101-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

ctDNA analysis GENETIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Non-small cell lung cancer (NSCLC)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital, Nanjing Medical University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Shenglin Ma, M.D

CONTACT

057156007908; mashenglin@medmail.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 27, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

CN (1)