PRospective rEgistry OF Advanced Stage cancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations to Address Disparities in Precision Medicine

The objective of this Study is to collect, process, and transfer biologic samples such as blood and/or tissue biopsies to determine the concordance of detected alterations obtained through liquid biopsy analyses compared to next generation sequencing of time-matched or archival tissue specimens from individuals with advanced solid tumors.Examples of locally advanced and metastatic tumors include stage III and IV cancers (ex. lung, breast, all gastrointestinal malignancies, all gynecologic malignancies, prostate cancer, head and neck tumors, soft tissue cancers, and melanoma). These specimens will be analyzed for diagnostic purposes and research (either by Labcorp/OmniSeq or to a third-party recipient designated by Labcorp/OmniSeq). Labcorp/OmniSeq may transfer the specimens and data to its clients, including commercial, academic or non-profit research institutions; or alternatively, may retain the specimens in its repository for future research use at the sole discretion of Labcorp/OmniSeq and or assignees. Labcorp/OmniSeq will maintain all detailed clinical information including demographic data (de-identified), ethnicity, disease state, stage (radiological, pathological and clinical-whichever is relevant).

Case Inclusion CriteriaAny gender, race, or ethnicity is acceptableMust be at least 18 years of ageAll subjects must fall into the following group:All Cases will be classified as following cohortsCohort lung cancer - Subject must meet the following criteria:Recently diagnosed advanced lung cancerLocally advanced and metastatic solid tumorsTreatment naïve (not yet treated or tumor removed; biopsy acceptable) and/or on treatmentPreviously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testingGyn malignancies (list ovarian and uterine cancer separately)Recently diagnosed advanced gynecological malignanciesLocally advanced and metastatic solid tumorsTreatment naïve (not yet treated or tumor removed; biopsy acceptable).Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testingGastrointestinal malignancies Cohort (list all cancers separately-colorectal, gastric, esophageal and pancreatic)Recently diagnosed advanced gastrointestinal malignancyLocally advanced and metastatic solid tumorsTreatment naïve (not yet treated or tumor removed; biopsy acceptable).Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testingMelanoma CohortRecently diagnosed advanced melanomaLocally advanced and metastatic solid tumorsTreatment naïve (not yet treated or tumor removed; biopsy acceptable).Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testingBreast cancer CohortRecently diagnosed advanced breast cancerLocally advanced and metastatic solid tumorsTreatment naïve (not yet treated or tumor removed; biopsy acceptable).Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testingHead and neck cancer CohortRecently diagnosed advanced head and neck cancerLocally advanced and metastatic solid tumorsTreatment naïve (not yet treated or tumor removed; biopsy acceptable).Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testingSarcoma and soft tissue cancer cohortRecently diagnosed advanced cancerLocally advanced and metastatic solid tumorsTreatment naïve (not yet treated or tumor removed; biopsy acceptable).Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testingProstate cancerRecently diagnosed advanced cancerLocally advanced and metastatic solid tumorsTreatment naïve (not yet treated or tumor removed; biopsy acceptable).Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testingAdditional RequirementsSubjects must be diagnosed by appropriate histopathologySubjects can have any concurrent diseasesMust voluntarily sign and understand the most current Institutional Review Board/Independent Ethics Committee (IRB/IEC) - approved Informed Consent Form (ICF) prior to study participation. Witness must sign the informed consent form if the subject is illiterate.Exclusion CriteriaSubjects incapable of understanding the items listed in the ICF and the consent processPregnant femalesSubjects with a history of or known psychiatric illness that deems them unable to consent