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
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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 |

- 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)
- 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 |
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;

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