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

Breast Cancer Clinical Trial

— PREFER  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697198
• Other study ID #: PREFER
• Status: Recruiting
• Start date: April 19, 2021
• Est. completion date: September 2024

Study information

• Verified date: April 2023
• Source: Labcorp Drug Development Inc
• Contact: Dhwani Mehta
• Phone: 551-998-3385
• Email: dmehta[@]cbcca.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• OmniSeq Test
Genomic and immune profiling assay for all solid tumors

Locations

Country	Name	City	State
United States	Clinical Site	Covington	Louisiana
United States	Clinical Site	Dublin	Georgia
United States	Clinical Site	Fort Payne	Alabama
United States	Clinical Site	Fort Wayne	Indiana
United States	Clinical Site	Huntersville	North Carolina
United States	Clinical Site	Orange City	Florida
United States	Clinical Site	Rock Hill	South Carolina
United States	Clinical Site	Stuart	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Labcorp Drug Development Inc

Country where clinical trial is conducted

United States, 

References & Publications (15)

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* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Giorgio Sirugo et al, The Missing Diversity in Human Genetic Studies. Cell. Accessed December 25, 2020
•   Jessica Kent. Health Affairs. Accessed December 25, 2020
•   National Cancer Institute. Cancer statistics (2018)
•   National Cancer Institute. Cancer types (2018)
•   Stanford Medicine. BRAICELET: Bio-Repository for American Indian Capacity, Education, Law, Economics and Technology [Internet]. Stanford Medicine; 2019.