Create a living biobank of PDOs from Stage I-III lung cancer patients.

The primary objective of this study is to compare Assay results to diagnoses determined by currently accepted standards for lung cancer detection. This will be accomplished by analysis of sputum samples from three cohorts including healthy Participants, high risk Participants, and cancer patient Participants using the Assay as developed in accordance with findings of bioAffinity protocol BA-001 to confirm assay results. Adjustments will be made as necessary to finalize Assay design for clinical trials and commercialization. The secondary objective of this study is to determine optimum methods for collection of sputum samples. Three sputum collection methods used by high risk Participants will be compared. Individuals at high risk for lung cancer will be assigned to one of three sputum collection cohorts including (1) acapella® airway assist device under medical supervision to obtain a single sputum sample; (2) acapella® airway assist device to obtain a sputum sample over a three-day period, and (3) individuals who under medical supervision will collect a single sputum sample assisted by nebulization of between 0.9% to 10% hypertonic saline. Samples will be compared to determine the optimal collection method for sample analysis by CyPath® Lung.

The PI is studying if sorafenib/hydroxychloroquine (HCQ) will have improved efficacy when compared to sorafenib alone and in patients progressing of sorafenib the addition of HCQ would lead to disease stability in patients with advanced hepatocellular cancer (HCC).

TLI and UTHSCSA will be participating in projects 2 and 4 ,To examine cirrhotic patients and their risk factors for developing liver cancer . Researchers hope to improve ability to prevent liver cancer , and to better identify patients at higher risk for developing liver cancer at an early stage. C. Early detection of HCC in patients with cirrhosis remains suboptimal. The efficacy of HCC surveillance for the early detection of HCC is a subject of intense debate due to the lack of sensitive and specific biomarkers that are well validated in prospective studies. Further, implementation of surveillance in practice is very low. The MIRA aims to develop novel, urgently needed, and highly effective surveillance biomarkers of patients with cirrhosis, and improve the utilization of currently available surveillance strategies. Project 2: Metabolic Syndrome and Risk Prediction of Hepatocellular Carcinoma (PI: H El-Serag). This project will develop risk stratification algorithms based on demographic, clinical, molecular and epidemiological risk profiles to identify cirrhotic patients who might benefit from chemoprevention or intensive surveillance. Our proposed multicenter prospective cohort study of >4000 patients with cirrhosis and up to 4 year follow up (a conservative estimate of 300 new HCC cases) will be the largest cohort study of cirrhotic patients assembled in Texas (and U.S). We will evaluate phenotypic (including molecular endophenotypes) and genotypic aspects of MetS as well as established risk factors.Project 4: Novel Biomarkers for Hepatocellular Carcinoma (PI: L Beretta). This project will identify and validate novel biomarkers for risk stratification and early HCC detection. Although several biomarkers have supporting pre-clinical (phase 1) and case-control (phase 2) data, few have been evaluated in retrospective cohort (phase 3) or prospective cohort (phase 4) studies. The prospective Texas multicenter cohort study of cirrhosis patients (i.e. Phase 3) in which 300 HCC cases will be compared to 600 controls nested in this cohort. We will validate several promising existing markers as well as aim to discover novel biomarkers for HCC detection.