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

  • Completed
  • Observational
  • Diagnostic Test
  • Labcorp Corporation of America Holdings, Inc
  • 18 Years -


Study Purpose

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).

Intervention

Diagnostic Test : OmniSeq Test


Eligibility Requirements

info icon Any gender, race, or ethnicity is acceptable

info icon Must be at least 18 years of age

info icon All subjects must fall into the following group:

info icon All Cases will be classified as following cohorts

info icon Cohort lung cancer - Subject must meet the following criteria:

info icon Recently diagnosed advanced lung cancer

info icon Locally advanced and metastatic solid tumors

info icon Treatment naïve (not yet treated or tumor removed; biopsy acceptable) and/or on treatment

info icon Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing

info icon Gyn malignancies (list ovarian and uterine cancer separately)

info icon Recently diagnosed advanced gynecological malignancies

info icon Locally advanced and metastatic solid tumors

info icon Treatment naïve (not yet treated or tumor removed; biopsy acceptable).

info icon Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing

info icon Gastrointestinal malignancies Cohort (list all cancers separately-colorectal, gastric, esophageal and pancreatic)

info icon Recently diagnosed advanced gastrointestinal malignancy

info icon Locally advanced and metastatic solid tumors

info icon Treatment naïve (not yet treated or tumor removed; biopsy acceptable).

info icon Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing

info icon Melanoma Cohort

info icon Recently diagnosed advanced melanoma

info icon Locally advanced and metastatic solid tumors

info icon Treatment naïve (not yet treated or tumor removed; biopsy acceptable).

info icon Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing

info icon Breast cancer Cohort

info icon Recently diagnosed advanced breast cancer

info icon Locally advanced and metastatic solid tumors

info icon Treatment naïve (not yet treated or tumor removed; biopsy acceptable).

info icon Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing

info icon Head and neck cancer Cohort

info icon Recently diagnosed advanced head and neck cancer

info icon Locally advanced and metastatic solid tumors

info icon Treatment naïve (not yet treated or tumor removed; biopsy acceptable).

info icon Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing

info icon Sarcoma and soft tissue cancer cohort

info icon Recently diagnosed advanced cancer

info icon Locally advanced and metastatic solid tumors

info icon Treatment naïve (not yet treated or tumor removed; biopsy acceptable).

info icon Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing

info icon Prostate cancer

info icon Recently diagnosed advanced cancer

info icon Locally advanced and metastatic solid tumors

info icon Treatment naïve (not yet treated or tumor removed; biopsy acceptable).

info icon Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing

info icon Additional Requirements

info icon Subjects must be diagnosed by appropriate histopathology

info icon Subjects can have any concurrent diseases

info icon 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.

info icon Subjects incapable of understanding the items listed in the ICF and the consent process

info icon Pregnant females

info icon Subjects with a history of or known psychiatric illness that deems them unable to consent

Recruiting status

Completed

Estimated enrollment

1429

 
Study start date

Apr 19, 2021

Study end date

Dec 31, 2024

Last updated

Mar 23, 2025

Primary purpose

N/A

Design

Observational

Intervention

Diagnostic Test

Study phase

N/A

Allocation

N/A

 

Sponsor:

Labcorp Corporation of America Holdings, Inc

Collaborator:

N/A

Investigator:

N/A

NCT05697198

Clinic Location Investigator Distance RECRUITING STATUS Contact