Clinical trial NCT05697198: PRospective REgistry of Advanced Stage CancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations to Address Disparities in Precision Medicine
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Labcorp Corporation of America Holdings, Inc
Sponsor class: INDUSTRY
First posted: 2023-01-25
Enrollment: 1429
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with advanced solid tumors

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).

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Payne
country: United States
facility: Clinical Site
state: Alabama
city: Orange City
country: United States
facility: Clinical Site
state: Florida
city: Stuart
country: United States
facility: Clinical Site
state: Florida
city: Dublin
country: United States
facility: Clinical Site
state: Georgia
city: Fort Wayne
country: United States
facility: Clinical Site
state: Indiana
city: Covington
country: United States
facility: Clinical Site
state: Louisiana
city: Huntersville
country: United States
facility: Clinical Site
state: North Carolina
city: Rock Hill
country: United States
facility: Clinical Site
state: South Carolina
Study officials:
References:
citation: Alizadeh AA, Eisen MB, Davis RE, Ma C, Lossos IS, Rosenwald A, Boldrick JC, Sabet H, Tran T, Yu X, Powell JI, Yang L, Marti GE, Moore T, Hudson J Jr, Lu L, Lewis DB, Tibshirani R, Sherlock G, Chan WC, Greiner TC, Weisenburger DD, Armitage JO, Warnke R, Levy R, Wilson W, Grever MR, Byrd JC, Botstein D, Brown PO, Staudt LM. Distinct types of diffuse large B-cell lymphoma identified by gene expression profiling. Nature. 2000 Feb 3;403(6769):503-11. doi: 10.1038/35000501.
citation: Guinney J, Dienstmann R, Wang X, de Reynies A, Schlicker A, Soneson C, Marisa L, Roepman P, Nyamundanda G, Angelino P, Bot BM, Morris JS, Simon IM, Gerster S, Fessler E, De Sousa E Melo F, Missiaglia E, Ramay H, Barras D, Homicsko K, Maru D, Manyam GC, Broom B, Boige V, Perez-Villamil B, Laderas T, Salazar R, Gray JW, Hanahan D, Tabernero J, Bernards R, Friend SH, Laurent-Puig P, Medema JP, Sadanandam A, Wessels L, Delorenzi M, Kopetz S, Vermeulen L, Tejpar S. The consensus molecular subtypes of colorectal cancer. Nat Med. 2015 Nov;21(11):1350-6. doi: 10.1038/nm.3967. Epub 2015 Oct 12.
citation: Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.
citation: Davies H, Bignell GR, Cox C, Stephens P, Edkins S, Clegg S, Teague J, Woffendin H, Garnett MJ, Bottomley W, Davis N, Dicks E, Ewing R, Floyd Y, Gray K, Hall S, Hawes R, Hughes J, Kosmidou V, Menzies A, Mould C, Parker A, Stevens C, Watt S, Hooper S, Wilson R, Jayatilake H, Gusterson BA, Cooper C, Shipley J, Hargrave D, Pritchard-Jones K, Maitland N, Chenevix-Trench G, Riggins GJ, Bigner DD, Palmieri G, Cossu A, Flanagan A, Nicholson A, Ho JW, Leung SY, Yuen ST, Weber BL, Seigler HF, Darrow TL, Paterson H, Marais R, Marshall CJ, Wooster R, Stratton MR, Futreal PA. Mutations of the BRAF gene in human cancer. Nature. 2002 Jun 27;417(6892):949-54. doi: 10.1038/nature00766. Epub 2002 Jun 9.
citation: Schwaederle M, Zhao M, Lee JJ, Lazar V, Leyland-Jones B, Schilsky RL, Mendelsohn J, Kurzrock R. Association of Biomarker-Based Treatment Strategies With Response Rates and Progression-Free Survival in Refractory Malignant Neoplasms: A Meta-analysis. JAMA Oncol. 2016 Nov 1;2(11):1452-1459. doi: 10.1001/jamaoncol.2016.2129.
citation: McShane LM, Cavenagh MM, Lively TG, Eberhard DA, Bigbee WL, Williams PM, Mesirov JP, Polley MY, Kim KY, Tricoli JV, Taylor JM, Shuman DJ, Simon RM, Doroshow JH, Conley BA. Criteria for the use of omics-based predictors in clinical trials. Nature. 2013 Oct 17;502(7471):317-20. doi: 10.1038/nature12564.
citation: McShane LM, Polley MY. Development of omics-based clinical tests for prognosis and therapy selection: the challenge of achieving statistical robustness and clinical utility. Clin Trials. 2013 Oct;10(5):653-65. doi: 10.1177/1740774513499458. Epub 2013 Sep 2.
citation: Lee CH, Yoon HJ. Medical big data: promise and challenges. Kidney Res Clin Pract. 2017 Mar;36(1):3-11. doi: 10.23876/j.krcp.2017.36.1.3. Epub 2017 Mar 31.
citation: Genevieve LD, Martani A, Shaw D, Elger BS, Wangmo T. Structural racism in precision medicine: leaving no one behind. BMC Med Ethics. 2020 Feb 19;21(1):17. doi: 10.1186/s12910-020-0457-8.
citation: Awasthi S, Berglund A, Abraham-Miranda J, Rounbehler RJ, Kensler K, Serna A, Vidal A, You S, Freeman MR, Davicioni E, Liu Y, Karnes RJ, Klein EA, Den RB, Trock BJ, Campbell JD, Einstein DJ, Gupta R, Balk S, Lal P, Park JY, Cleveland JL, Rebbeck TR, Freedland SJ, Yamoah K. Comparative Genomics Reveals Distinct Immune-oncologic Pathways in African American Men with Prostate Cancer. Clin Cancer Res. 2021 Jan 1;27(1):320-329. doi: 10.1158/1078-0432.CCR-20-2925. Epub 2020 Oct 9.
citation: Bentley AR, Callier S, Rotimi CN. Diversity and inclusion in genomic research: why the uneven progress? J Community Genet. 2017 Oct;8(4):255-266. doi: 10.1007/s12687-017-0316-6. Epub 2017 Jul 18.
citation: O'Donnell PH, Dolan ME. Cancer pharmacoethnicity: ethnic differences in susceptibility to the effects of chemotherapy. Clin Cancer Res. 2009 Aug 1;15(15):4806-14. doi: 10.1158/1078-0432.CCR-09-0344. Epub 2009 Jul 21.
citation: Shaw DM, Elger BS, Colledge F. What is a biobank? Differing definitions among biobank stakeholders. Clin Genet. 2014 Mar;85(3):223-7. doi: 10.1111/cge.12268. Epub 2013 Oct 16.
citation: UK Biobank data on 500,000 people paves way to precision medicine. Nature. 2018 Oct;562(7726):163-164. doi: 10.1038/d41586-018-06950-9. No abstract available.
citation: Tutton R. Biobanks and the inclusion of racial/ethnic minorities. Race/ Ethnicity: Multidisciplinary Global Contexts; 2009. p. 75-95.