Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Multiple Pulmonary Nodules

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

High-risk patients eligible for lung cancer screening but with negative radiographic findings on CT screening (Lung RADS ≤2).

1. ≥30 pack-year history of cigarette smoking
2. ≥55 years of age
3. Current smoker or quit within the past 15 years

Patients with lung nodules ≥ 6 mm on routine (non-lung cancer screening) CT evaluation deemed suspicious for malignancy by initial physician judgment but not malignant by ≥2 years of radiographic stability and consensus clinical opinion.

1- Age ≥40 years.

Patients with lung cancer (histologically proven or presumed by consensus opinion of tumor board); prior to definitive therapy.

1- Age ≥40 years.

High-risk patients with newly diagnosed suspicious nodule of Lung RADS ≥3 on CT screening.

1. ≥30 pack-year history of cigarette smoking
2. ≥55 years of age
3. Current smoker or quit within the past 15 years

Patients with newly diagnosed incidentally-found lung nodules ≥ 6 mm on routine CT evaluation deemed suspicious for malignancy by physician judgment.

1- Age ≥40 years.

Patients with previously treated lung cancer (histologically proven or by consensus opinion); status-post completion of definitive therapy (resection +/- chemotherapy or SBRT with curative intent) within the previous year with no current evidence of disease.

1- Age ≥40 years.

Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease.

Guardant Health ct-DNA LUNAR assay

Mehrdad Arjomandi, MD

Mehrdad Arjomandi, M.D.

This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, University of California, San Francisco (UCSF) Medical Center, and the San Francisco General Hospital. The proposed study will comprise of two primary populations to determine the ctDNA assay performance in a variety of clinical settings.

Study objectives and statistical approaches to achieve those objectives are determined at the level of the populations described below:

Population 1: Sensitivity and Specificity Thresholding.

In this phase, the technical feasibility of the intended use case will be assessed in the intended use population relative to known cancer status as established by standard clinical methods. ctDNA samples from enrolled patients will be assessed in each of the following cohorts:

Cohort 1A: High-risk patients negative for lung cancer by CT screening and clinical follow-up.

Cohort 1B: Patients with lung nodules ≥6 mm by CT but negative for lung cancer by extended (3 years) CT screening follow-up.

Cohort 1C: Patients with lung cancer (histologically proven or by consensus tumor board opinion of ≥90% probability of cancer) prior to definitive therapy.

Population 2: Clinical Intended Use Performance. In this phase, the clinical performance of the ctDNA assay will be evaluated in patients with high clinical suspicion for lung cancer. ctDNA will be compared to the clinical diagnosis made according to the standard of care (e.g. biopsy, CT surveillance, etc.). ctDNA samples from enrolled patients will be assessed in each of the following cohorts:

Cohort 2A: High-risk patients newly positive (Lung imaging Reporting And Data System (Lung-RADS) \>=3) by CT screening.

Cohort 2B: Patients with \>= 6 mm lung nodules suspicious for lung cancer by treating physician judgment.

Cohort 2C: Patients with a personal history of lung cancer after completion of curative intent treatment but without evidence of recurrence.

Specific Aim 1: To estimate the ctDNA assay sensitivity and specificity requirements in the specific clinical use populations using patients with known non-small cell lung cancer status.

Specific Aim 2: To prospectively estimate the ctDNA assay clinical performance in the clinical application of interest.

ENDPOINTS

Primary Endpoints

Specific Aim 1: Estimation of the ctDNA assay's clinical sensitivity and specificity in patients with lung cancer as proven by histology or tumor board consensus opinion\* and in patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening follow-up\*\*.

\*Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion is ≥90% and the biopsy risk is high.

\*\*Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and consensus clinical opinion.

Specific Aim 2: Estimation of the ctDNA assay's clinical predictive value relative to standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk and general populations (the clinical applications of interest).

Secondary Endpoints

* Correlation of the ctDNA assay performance with Lung-RADS radiographic criteria
* Correlation of Lung-RADS with disease truth defined by clinical follow up as the definite gold standard

Exploratory Endpoints

* Correlation of plasma and tissue genotyping results
* Correlation of the ctDNA assay with orthogonal reference technologies (e.g. ddPCR)
* Correlation of the ctDNA assay performance with histologic sub-type and clinical course (e.g. aggressive vs. indolent disease)
* Correlation of the ctDNA assay performance with clinical lung cancer risk factors
* Correlation of the ctDNA assay results pre-and post-resection
* Correlation of follow-up the ctDNA assay results and kinetics vs. clinical recurrence post-resection or radiotherapy
* Estimation of theoretical biopsy avoidance rate in clinical use population.

The goal of this study is to evaluate the ability of cell-free circulating tumor DNA (ctDNA) using Guardant Health's LUNAR technology to detect early stage in lung cancer as compared to healthy volunteers and those patients at high risk for lung cancer, but without a lung cancer diagnosis. ctDNA arises when DNA fragments are released into the bloodstream after cell death and is distinguished from non-cancerous cell-free DNA (cfDNA) by the presence of somatic alterations, e.g. mutations, gene amplifications, and fusions. In advanced stage non-small cell lung cancer (NSCLC), evaluation of ctDNA in plasma can be used detect the presence of resistance mutations and ultimately guide treatment while obviating the need for tissue biopsy.

Biomarkers for Risk Stratification in Lung Cancer

Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening

Estimation of the ctDNA assay's clinical sensitivity and specificity in patients with lung cancer as proven by histology or tumor board consensus opinion\* and in patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening follow-up\*\*.

\*Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion is ≥90% and the biopsy risk is high.

Estimation of the ctDNA assay's clinical predictive value relative to standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk and general populations (the clinical applications of interest).

Northern California Institute of Research and Education

Guardant Health, Inc.

University of California, San Francisco

Mediastinal Neoplasms

Mediastinal Diseases

Thoracic Diseases

Thoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports.

Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision

Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Thoracoscopic surgery

Chiu-kuei Nien

The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.

Needlescopic-assisted Uniportal vs Uniportal VATS

Needlescopic-assisted Uniportal VATS Versus Conventional Uniportal VATS. A Randomized Prospective Noninferiority Study

Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)

Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)

Out patient documented using PainDETECT questionnaire (PD-Q)

Total opioid equivalent dose used during post-operative course

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biomarkers for Risk Stratification in Lung Cancer	NCT03774758	Nodule Solitary... Non-small Cell ...	Guardant Health...	40 Years -	University of California, San Francisco
Needlescopic-assisted Uniportal vs Uniportal VATS	NCT03439696	Lung Cancer Lung Cancer Met... Bullous Disease... Nodule Solitary... Mediastinal Tum...	Thoracoscopic s...	20 Years - 90 Years	National Taiwan University Hospital Hsin-Chu Branch
Biomarkers for Risk Stratification in Lung Cancer	NCT03774758	Nodule Solitary... Non-small Cell ...	Guardant Health...	40 Years -	University of California, San Francisco
Needlescopic-assisted Uniportal vs Uniportal VATS	NCT03439696	Lung Cancer Lung Cancer Met... Bullous Disease... Nodule Solitary... Mediastinal Tum...	Thoracoscopic s...	20 Years - 90 Years	National Taiwan University Hospital Hsin-Chu Branch

Spots Global Cancer Trial Database for nodule solitary pulmonary