Lung Neoplasms
Conditions
Brief summary
Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.
Detailed description
Fresh tumor tissues and matched blood cells will be analyzed by large-panel (Berryoncology, lnc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, tumor mutational burden (TMB), microsatellite instability (MSI) status, etc., Therapeutic approach and outcome will be followed-up to inspect the clinical benefit by large-panel analysis. In addition, selected samples will be analyzed by WES to assess the correctness of TMB estimated by large-panel.
Interventions
All samples were detected by large-panel, whereas some of which were also detected by WES.
Sponsors
Shanghai Chest Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant aged 18 or above, and gender unrestricted * Individual with pathologically diagnosed lung cancer
Exclusion criteria
* Patients with concomitant other tumors * Individual with severe cardiopulmonary insufficiency and hypoproteinemia * Women who were pregnant and were during their lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | through the whole study period, an average of 3 year | PFS refers to the time from initial treatment to the time of disease progression or death |
| Tumor Mutational Burden (TMB) | halfway of the study, an average of 1.5 year | TMB is defined as the total number of detected somatic mutation counts in coding regions per million bases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other biomarkers | halfway of the study, an average of 1.5 year | The distribution and clinical application value of molecular biomarkers such as Neoantigen, MSI and LOH in Chinese lung cancer patients |
| Clonality | halfway of the study, an average of 1.5 year | The tumor clonality in Chinese lung cancer patients |
| Overall survival (OS) | through the whole study period, an average of 3 year | OS refers to the time from the patient entering into the group to the time of death |
Countries
China
Contacts
Primary ContactNiu Xiaomin
Outcome results
None listed