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

NCT05697198 | Completed

• 1 other identifier: PREFER
• Study Type: observational
• Target: 1,429
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Lung Cancer; Ovarian Cancer; Uterine Cancer; Colorectal Cancer; Stomach Cancer; Esophageal Cancer; Pancreatic Cancer; Melanoma; Breast Cancer; Head and Neck Cancer; Soft Tissue Sarcoma; Rhabdomyosarcoma; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Study Arms (8)

Cohort lung cancer

Diagnostic Test: OmniSeq Test

Gyn malignancies

Diagnostic Test: OmniSeq Test

Gastrointestinal malignancies Cohort

Diagnostic Test: OmniSeq Test

Melanoma Cohort

Diagnostic Test: OmniSeq Test

Breast cancer Cohort

Diagnostic Test: OmniSeq Test

Head and neck cancer Cohort

Diagnostic Test: OmniSeq Test

Sarcoma and soft tissue cancer cohort

Diagnostic Test: OmniSeq Test

Prostate cancer

Diagnostic Test: OmniSeq Test

Interventions

OmniSeq Test DIAGNOSTIC_TEST

Genomic and immune profiling assay for all solid tumors

Breast cancer Cohort; Cohort lung cancer; Gastrointestinal malignancies Cohort; Gyn malignancies; Head and neck cancer Cohort; Melanoma Cohort; Prostate cancer; Sarcoma and soft tissue cancer cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with advanced solid tumors

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Labcorp Corporation of America Holdings, Inc: lead

Study Sites (8)

Clinical Site

Fort Payne, Alabama, 35958, United States

Location

Clinical Site

Orange City, Florida, 32763, United States

Location

Clinical Site

Stuart, Florida, 34994, United States

Location

Clinical Site

Dublin, Georgia, 31021, United States

Location

Clinical Site

Fort Wayne, Indiana, 46804, United States

Location

Clinical Site

Covington, Louisiana, 70433, United States

Location

Clinical Site

Huntersville, North Carolina, 28078, United States

Location

Clinical Site

Rock Hill, South Carolina, 29732, United States

Location

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  BACKGROUND

Related Links

• National Cancer Institute. Cancer statistics (2018)
• National Cancer Institute. Cancer types (2018)
• Jessica Kent. Health Affairs. Accessed December 25, 2020
• Giorgio Sirugo et al, The Missing Diversity in Human Genetic Studies. Cell. Accessed December 25, 2020

Biospecimen

Retention: SAMPLES WITH DNA

In the optional biobank component of the study, participants may elect to give a blood sample that will be stored in cell-free DNA streck tubes for future research use

MeSH Terms

Conditions

Lung Neoplasms; Ovarian Neoplasms; Uterine Neoplasms; Colorectal Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Pancreatic Neoplasms; Melanoma; Breast Neoplasms; Head and Neck Neoplasms; Sarcoma; Rhabdomyosarcoma; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Esophageal Diseases; Pancreatic Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases; Neoplasms, Connective and Soft Tissue; Myosarcoma; Neoplasms, Muscle Tissue; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 25, 2023
• Study Start: April 19, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

US (8)