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CompletedNot applicableNCT05697198
Official study title

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

Study summary

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).

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedOmniSeq Test

The study team can explain what participation involves.

Who it may be forLocally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 6, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Labcorp Corporation of America Holdings, Inc

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting
Locally advanced→Metastatic or stage IV→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Case
  • 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.
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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