Lung Cancer
Conditions
Keywords
Bronchoscopy, Liquid biopsy, Lung Cancer, Next Generation Sequencing
Brief summary
This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.
Detailed description
This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of genetic alterations using Next Generation Sequencing in patients suspicious of early-stage lung cancer.
Interventions
DIAGNOSTIC_TESTUltarthin bronchoscopy with intratumoral washing
Each subject suspected of early-stage, resectable lung cancer will undergo bronchooscopic procedure. Ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Subsequently, intratumoral washing is performed. After undergoing surgery for suspected early-stage lung cancer, the analysis of next generation sequencing is conducted on intratumoral washing, tissue from surgical specimen, and blood.
Sponsors
Pusan National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Inclusion Criteria: * Age ≥ 20 years * Obtained written informed consent * Subjects suspected of having resectable lung cancer on computed tomography * Subjects without contraindication to brochoscopy * Subjects planning to undergo surgery for suspected lung cancer and opting for tissue or liquid biopsy for genetic alteration using Next Generation Sequencing 2.
Exclusion criteria
* Subjects who withdraw informed consent * Subjects who are unable to undergo liquid biopsy (plasma) and tissue biopsy - for genetic alteration with Next Generation Sequencing based on the investigator's judgement * Subjects diagnosed with a cancer other than non-small cell lung cancer from the lung tissue lesion * Subjects diagnosed with a benign lesion from the lung tissue lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic accuracy of genetic alterations in intratumoral washing fluid using Next Generation Sequencing | through study completion, an average of 1 year | Diagnostic accuracy is defined as the number of true positive and true negative genetic alterations detected by Next Generation Sequencing, divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Turn-around time | through study completion, an average of 1 year | The duration between an order request and the task completion in in intratumoral washing fluid compared with plasma and tissue (gold standard). |
| Sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid | through study completion, an average of 1 year | The sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid compared with tissue (gold standard). |
| Detection rate of clinically significant actionable mutations among intratumoral washing fluid, plasma, and tissue | through study completion, an average of 1 year | Detection rate is defined as the number of genetic alterations detected by Next Generation Sequencing divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy. Clinically significant actionable mutations are defined as genes with corresponding drugs, either approved or under clinical trial (e.g., EGFR, ALK, ROS1, BRAF V600E, RET, NTRK, KRAS G12C, FGFR3, or HER2). |
| Concordance rate of genetic alterations detected by Next Generation Sequencing among intratumoral washing fluid, plasma, and tissue | through study completion, an average of 1 year | The concordance rate of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid, compared with plasma and tissue (gold standard). |
| Detection rate of co-mutations among intratumoral washing fluid, plasma, and tissue | through study completion, an average of 1 year | Detection rate is defined as the number of genetic alterations detected by Next Generation Sequencing divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy. Co-mutations are defined as the occurrence of two or more genetic alterations within the same tumor cells in an individual, including at least one actionable mutation (e.g., TP53, DNMT3A, TET2, CTNNB1, PIK3CA, RB1, STK11). |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORJung-Seop Eom, MD, PhD
Pusan National University Hospital
Outcome results
None listed