- 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
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.
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
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
Publications
Tutton R. Biobanks and the inclusion of racial/ethnic minorities. Race/ Ethnicity: Multidisciplinary Global Contexts; 2009. p. 75-95.
Websites
National Cancer Institute. Cancer statistics (2018)
National Cancer Institute. Cancer types (2018)
NCT05697198
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