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

• ClinicalTrials.gov Identifier: NCT05697198
• Recruitment Status: Recruiting
• First Posted: January 25, 2023
• Last Update Posted: April 27, 2023
• Sponsor: Labcorp Corporation of America Holdings, Inc
• Information provided by (Responsible Party): Labcorp Corporation of America Holdings, Inc

Study Description

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).

Condition or disease	Intervention/treatment
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	Diagnostic Test: OmniSeq Test

Detailed Description:

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:

• The biorepository registry will collect clinical data, store biological specimens, and maintain additional associated information for future use in research.
• The biorepository will address healthcare disparities by increasing representative samples of tissues available for research from community oncology practices to reflect ethnicity and social determinants of health (SDOH). The biorepository would create catalogs of different mutations and/or germline information in different ethnicities for future drug development.
• The biorepository will ensure the quality of data, enhance research, and manage the accessibility and distribution/disposition of biospecimens in its collection.
• The biorepository will develop a tissue bank for serious malignant disorders with appropriate clinical data points that will support the development of newer molecules for targeted therapy. This will facilitate expansion of indications of existing molecules by providing better understanding of RNA/DNA derived anomalies and diseases as well as response criteria.

Contribution to Science:

• The PREFER registry and biorepository would collect clinical data, maintain biological specimens, and associated information, for future use in research.
• The biorepository would address healthcare disparities representing samples of biospecimens for the research from rural population

The seven steps to establish and operationalize of Labcorp/Omniseq biorepository:

1. Informed consent (includes permission to commercialize use of specimens at a future date to develop drugs at the sole discretion of Labcorp/OmniSeq)
2. Data Collection: All relevant clinical information will be entered in a central data repository. Data will include a unique identifier, demographic data, as well as all data points discussed previously
3. Sample collection: Since patient will be undergoing standard diagnostic work up for suspected primary malignant disorder as a standard course of action at the point of care (POC) facility, the registry will not be adding any additional invasive clinical or diagnostic intervention
4. Sample Processing/Shipping and Handling (Per SOP)
5. Electronic Case Report From (ECRF) and data point to be entered by POC Facility
6. Storage or inventory
7. Retrieval, Redistribution of biological specimens

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 2500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Official Title: PRospective rEgistry OF Advanced Stage cancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations Using the OmniSeq Test and Creation of a Biobank From Community Cancer Clinics in the United States to Address Disparities in Precision Medicine
• Actual Study Start Date: April 19, 2021
• Estimated Primary Completion Date: September 2024
• Estimated Study Completion Date: September 2024

Groups and Cohorts

Group/Cohort	Intervention/treatment
Cohort lung cancer	Diagnostic Test: OmniSeq Test; Genomic and immune profiling assay for all solid tumors
Gyn malignancies	Diagnostic Test: OmniSeq Test; Genomic and immune profiling assay for all solid tumors
Gastrointestinal malignancies Cohort	Diagnostic Test: OmniSeq Test; Genomic and immune profiling assay for all solid tumors
Melanoma Cohort	Diagnostic Test: OmniSeq Test; Genomic and immune profiling assay for all solid tumors
Breast cancer Cohort	Diagnostic Test: OmniSeq Test; Genomic and immune profiling assay for all solid tumors
Head and neck cancer Cohort	Diagnostic Test: OmniSeq Test; Genomic and immune profiling assay for all solid tumors
Sarcoma and soft tissue cancer cohort	Diagnostic Test: OmniSeq Test; Genomic and immune profiling assay for all solid tumors
Prostate cancer	Diagnostic Test: OmniSeq Test; Genomic and immune profiling assay for all solid tumors

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 2 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Individuals with advanced solid tumors

Criteria

Case Inclusion Criteria

• 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.

Exclusion 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

Contacts and Locations

Contacts

Contact: Dhwani Mehta; 551-998-3385; dmehta@cbcca.net

Locations

United States, Alabama

Clinical Site; Recruiting

Fort Payne, Alabama, United States, 35958

United States, Florida

Clinical Site; Recruiting

Orange City, Florida, United States, 32763

Clinical Site; Recruiting

Stuart, Florida, United States, 34994

United States, Georgia

Clinical Site; Recruiting

Dublin, Georgia, United States, 31021

United States, Indiana

Clinical Site; Recruiting

Fort Wayne, Indiana, United States, 46804

United States, Louisiana

Clinical Site; Recruiting

Covington, Louisiana, United States, 70433

United States, North Carolina

Clinical Site; Recruiting

Huntersville, North Carolina, United States, 28078

United States, South Carolina

Clinical Site; Recruiting

Rock Hill, South Carolina, United States, 29732

Sponsors and Collaborators

Labcorp Corporation of America Holdings, Inc

More Information

Additional Information:

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 

Stanford Medicine. BRAICELET: Bio-Repository for American Indian Capacity, Education, Law, Economics and Technology [Internet]. Stanford Medicine; 2019. 

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• Responsible Party: Labcorp Corporation of America Holdings, Inc
• ClinicalTrials.gov Identifier: NCT05697198
• Other Study ID Numbers: PREFER
• First Posted: January 25, 2023
• Last Update Posted: April 27, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Sarcoma; Rhabdomyosarcoma; Stomach Neoplasms; Uterine Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases; Urogenital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms by Histologic Type; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Neoplasms, Connective and Soft Tissue; Myosarcoma; Neoplasms, Muscle Tissue; Stomach Diseases; Uterine Diseases