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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 : 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

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 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

Resource links provided by the National Library of Medicine





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



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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;

Information from the National Library of Medicine

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

Locations
China, Zhejiang
Hangzhou First People's Hospital, Nanjing Medical University Not yet recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Shirong Zhang, Ph.D    057156007664 ext 086    shirley4444@gmail.com   
Sponsors and Collaborators
First People's Hospital of Hangzhou

Responsible Party: First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT02946216     History of Changes
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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type