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).
Checked against the public recordLast updated Mar 6, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Labcorp Corporation of America Holdings, Inc
- Interventions being studied
- Diagnostic Test: OmniSeq Test
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Case Inclusion Criteria * Any gender, race, or ethnicity is acceptable * Must be at least 18 years of age * All subjects must fall into the following group: All Cases will be classified as following cohorts Cohort lung cancer - Subject must meet the following criteria: * Recently diagnosed advanced lung cancer * Locally advanced and metastatic solid tumors * Treatment naïve (not yet treated or tumor removed; biopsy acceptable) and/or on treatment * Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing Gyn malignancies (list ovarian and uterine cancer separately) * Recently diagnosed advanced gynecological malignancies * Locally advanced and metastatic solid tumors * Treatment 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 testing Gastrointestinal malignancies Cohort (list all cancers separately-colorectal, gastric, esophageal and pancreatic) * Recently diagnosed advanced gastrointestinal malignancy * Locally advanced and metastatic solid tumors * Treatment 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 testing Melanoma Cohort * Recently diagnosed advanced melanoma * Locally advanced and metastatic solid tumors * Treatment 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 testing Breast cancer Cohort * Recently diagnosed advanced breast cancer * Locally advanced and metastatic solid tumors * Treatment 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 testing Head and neck cancer Cohort * Recently diagnosed advanced head and neck cancer * Locally advanced and metastatic solid tumors * Treatment 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 testing Sarcoma and soft tissue cancer cohort * Recently diagnosed advanced cancer * Locally advanced and metastatic solid tumors * Treatment 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 testing Prostate cancer * Recently diagnosed advanced cancer * Locally advanced and metastatic solid tumors * Treatment 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 testing Additional Requirements * Subjects must be diagnosed by appropriate histopathology * Subjects can have any concurrent diseases * Must 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 Criteria * Subjects incapable of understanding the items listed in the ICF and the consent process * Pregnant females * Subjects with a history of or known psychiatric illness that deems them unable to consent
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Clinical SiteFort Payne, Alabama
- Clinical SiteOrange City, Florida
- Clinical SiteStuart, Florida
- Clinical SiteDublin, Georgia
- Clinical SiteFort Wayne, Indiana
- Clinical SiteCovington, Louisiana
- Clinical SiteHuntersville, North Carolina
- Clinical SiteRock Hill, South Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 6, 2025. Always confirm current availability with the study team.