An observational study in Lung Cancer, Ovarian Cancer and Uterine Cancer, sponsored by Labcorp Corporation of America Holdings, Inc. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Labcorp Corporation of America Holdings, Inc · Observational
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).
The scope of this pilot includes increasing uptake of personalized medicine (PM) testing using the OmniSeq test for identifying actionable target mutations in clinically appropriate patients and improving the quality of care particularly in practices providing care to minority and underserved patient populations. The research scope of this pilot covers 3 major areas that are necessary to understand the feasibility and best approaches.
i. How to identify appropriate steps and strategies to improve compliance to achieve optimum testing for all cancer patients, including all minority patients, in accordance with approved guidelines.
ii. How to contact, trace and test all eligible patients and impact outcomes to prevent future cancers in unaffected relatives
iii. Impact of trace back approach to identify, test, and guide appropriate clinical management and intervention in patients already diagnosed with eligible cancer types who have not yet been tested. This can be done by: 1) searching pathology records or tumor registry databases 2) community engagement campaigns and 3) self-referral based on family (and/or personal) cancer history.
The PREFER Registry will enable Labcorp/OmniSeq to create a biorepository in addition to a registry. The benefits are as follows:
Contribution to Science:
The seven steps to establish and operationalize of Labcorp/Omniseq biorepository:
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 1,429 is above the median of 121 across 238 observational studies indexed under Sarcoma.
Browse Sarcoma studies →This is the only study on the registry with Labcorp Corporation of America Holdings, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Individuals with advanced solid tumors
Case Inclusion Criteria
All Cases will be classified as following cohorts
Cohort lung cancer - Subject must meet the following criteria:
Gyn malignancies (list ovarian and uterine cancer separately)
Gastrointestinal malignancies Cohort (list all cancers separately-colorectal, gastric, esophageal and pancreatic)
Melanoma Cohort
Breast cancer Cohort
Head and neck cancer Cohort
Sarcoma and soft tissue cancer cohort
Prostate cancer
Additional Requirements
Exclusion Criteria
Diagnostic Test: OmniSeq Test
Diagnostic Test: OmniSeq Test
Diagnostic Test: OmniSeq Test
Diagnostic Test: OmniSeq Test
Diagnostic Test: OmniSeq Test
Diagnostic Test: OmniSeq Test
Diagnostic Test: OmniSeq Test
Diagnostic Test: OmniSeq Test
Genomic and immune profiling assay for all solid tumors
The percent adoption of the OmniSeq next generation sequencing (NGS) testing platform in an advanced cancer patient population compared to baseline over a 2 year period
Time frame: 2 years
Plan to share: Undecided
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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