What this trial measures

• Implement organoid culture technologies.Baseline

  NYSCF will establish patient specific tumor models known as organoids. Organoids are three dimensional cell culture laboratory models with self-organizing capabilities and long-term expansion potential that recapitulate the tissue they are derived from at the histological, molecular, and phenotypic level. We will create organoids from each subject sample collected. Primary outcome measure is successful growth of organoids from individual tumor samples.

• Validate genotypic and phenotypic relevance of tumor-derived organoids for biobanking.Baseline

  To ensure the validity of outcome 1, NYSCF will perform a series of molecular and histological evaluations in primary tissues versus the derived organoid model.

• Establish functional testing using organoid cultures alone or in combination with additional cell types.Baseline

  To validate the clinical utility of the organoid models and the discovery of novel therapeutic strategies, NYSCF will establish methodologies to evaluate organoid responses (i.e., genetic, phenotypic, morphological changes) to small molecules and/or additional treatment modalities such as immunotherapies, antibody-based therapeutics, and others.

• Perform drug testing and screens to identify new targets and/or new therapeutic strategies to effectively treat cancer.Baseline

  As with outcome 3, to validate the clinical utility of the organoid models and the discovery of novel therapeutic strategies, NYSCF will establish methodologies to evaluate organoid responses (i.e., genetic, phenotypic, morphological changes) to small molecules and/or additional treatment modalities such as immunotherapies, antibody-based therapeutics, and others.

• Develop a Laboratory Developed Test (LDT) for CLEP/FDA approval that will inform clinicians of each patient's tumor responses to FDA approved drugs.Baseline

  Tumor organoid models have been shown to recapitulate patient's responses to certain chemotherapies, radiation, and combination regimens used as standard of care. These models hold an unprecedented potential to predict patient's responses preclinically and become an additional resource that clinicians can use to inform treatment decisions. NYSCF will adapt the methodology developed in Outcome 4 to an assay performed under clinical laboratory standards and regulation to pursue clinical certification/FDA approval as per regulatory requirements.

• Develop stem cells from individual patient samples to study tumor evolution.Baseline

  Induced pluripotent stem cells are an invaluable source of patient material with unlimited self-renewal potential that can be used to generate any cell type in the body. By creating iPSCs from each patient's material received at our labs, NYSCF will generate the relevant cell tissue type to study the contribution of germline genetic risk factors to the development of each patient's specific cancers so that we can understand the mechanisms driving tumor evolution and adaptation to therapies as well as the potential of environmental factors and/or the role of immune surveillance that may determine the development of malignant disease. These studies may also lead to the identification of biomarkers for early detection and/or for more effective surveillance before recurrence occurs.