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

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ClinicalTrials.gov Identifier: NCT02946216
Recruitment Status : Unknown
Verified October 2016 by First People's Hospital of Hangzhou.
Recruitment status was:  Not yet recruiting
First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
First People's Hospital of Hangzhou

Study Description
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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
Non-small Cell Lung Cancer Stage III Non-Small-Cell Lung Cancer Metastatic Adenocarcinoma of Lung EGFR Wildtype Genetic: ctDNA analysis

Study Design
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Study Type : Observational
Estimated 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 : November 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART) [ Time Frame: 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)

  2. Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART) after crizotinib resistance [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Non-small cell lung cancer (NSCLC)
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946216


Contacts
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Contact: Shenglin Ma, M.D 057156007908 ext 086 mashenglin@medmail.com.cn

Locations
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China, Zhejiang
Hangzhou First People's Hospital, Nanjing Medical University
Hangzhou, Zhejiang, China, 310006
Contact: Shirong Zhang, Ph.D    057156007664 ext 086    shirley4444@gmail.com   
Sponsors and Collaborators
First People's Hospital of Hangzhou
More Information
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Responsible Party: First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT02946216    
Other Study ID Numbers: 2016-101-01
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma of Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type