Lung CancerPREFERNCT05697198
PRospective REgistry of Advanced Stage CancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations to Address Disparities in Precision Medicine
An observational study of Lung Cancer and Ovarian Cancer, run by Labcorp Corporation of America Holdings, Inc at 8 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Ovarian Cancer, Uterine Cancer
- What is being tested?
- OmniSeq Test
- How many people
- 1,429 participants
- Where
- 8 sitesUnited States
- Study dates
- 19 Apr 2021to 31 Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with advanced solid tumors
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Clinical Site
Covington, Louisiana, 70433
Clinical Site
Dublin, Georgia, 31021
Clinical Site
Fort Payne, Alabama, 35958
Clinical Site
Fort Wayne, Indiana, 46804
Clinical Site
Huntersville, North Carolina, 28078
Clinical Site
Orange City, Florida, 32763
Clinical Site
Rock Hill, South Carolina, 29732
Clinical Site
Stuart, Florida, 34994
About this study
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
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).
Read the 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.
- 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:
- Informed consent (includes permission to commercialize use of specimens at a future date to develop drugs at the sole discretion of Labcorp/OmniSeq)
- 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
- 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
- Sample Processing/Shipping and Handling (Per SOP)
- Electronic Case Report From (ECRF) and data point to be entered by POC Facility
- Storage or inventory
- Retrieval, Redistribution of biological specimens
- Conditions
- Lung Cancer, Ovarian Cancer, Uterine Cancer, Colorectal Cancer, Stomach Cancer, Esophageal Cancer
- Being tested
- OmniSeq Test
- Medical subject headings
- Lung Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Pancreatic Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmniSeq TestDiagnostic test
Genomic and immune profiling assay for all solid tumors
| Study group | Role | What they receive |
|---|---|---|
| Cohort lung cancer | Not described Receives: Diagnostic Test: OmniSeq Test | |
| Gyn malignancies | Not described Receives: Diagnostic Test: OmniSeq Test | |
| Gastrointestinal malignancies Cohort | Not described Receives: Diagnostic Test: OmniSeq Test | |
| Melanoma Cohort | Not described Receives: Diagnostic Test: OmniSeq Test | |
| Breast cancer Cohort | Not described Receives: Diagnostic Test: OmniSeq Test | |
| Head and neck cancer Cohort | Not described Receives: Diagnostic Test: OmniSeq Test | |
| Sarcoma and soft tissue cancer cohort | Not described Receives: Diagnostic Test: OmniSeq Test | |
| Prostate cancer | Not described Receives: Diagnostic Test: OmniSeq Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start19 Apr 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,429 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Labcorp Corporation of America Holdings, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697198
- Sponsor's protocol ID
- PREFER
- Acronym
- PREFER
- Status last verified
- Mar 2025
- First submitted
- 21 Dec 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 10676951Guinney 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.
PubMed 26457759Perou 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.
PubMed 10963602Davies 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.
PubMed 12068308Schwaederle 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.
PubMed 27273579McShane 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.
PubMed 24132288McShane 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.
PubMed 24000377Lee 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.
PubMed 28392994Genevieve 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.
PubMed 32075640Awasthi 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.
PubMed 33037017Bentley 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.
PubMed 28770442O'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.
PubMed 19622575Shaw 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.
PubMed 24001330UK 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.
PubMed 30365879Tutton R. Biobanks and the inclusion of racial/ethnic minorities. Race/ Ethnicity: Multidisciplinary Global Contexts; 2009. p. 75-95.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05697198
- Acronym / sponsor ID
- PREFER / PREFER
- Conditions
- Lung Cancer, Ovarian Cancer, Uterine Cancer, Colorectal Cancer, Stomach Cancer, Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,429 participants (actual)
- Lead sponsor
- Labcorp Corporation of America Holdings, IncIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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:
- Informed consent (includes permission to commercialize use of specimens at a future date to develop drugs at the sole discretion of Labcorp/OmniSeq)
- 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
- 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
- Sample Processing/Shipping and Handling (Per SOP)
- Electronic Case Report From (ECRF) and data point to be entered by POC Facility
- Storage or inventory
- Retrieval, Redistribution of biological specimens
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with advanced solid tumors
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmniSeq TestGenomic and immune profiling assay for all solid tumors | Diagnostic test | 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 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 10676951Alizadeh 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.
- Background: PubMed 26457759Guinney 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.
- Background: PubMed 10963602Perou 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.
- Background: PubMed 12068308Davies 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.
- Background: PubMed 27273579Schwaederle 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.
- Background: PubMed 24132288McShane 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.
- Background: PubMed 24000377McShane 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.
- Background: PubMed 28392994Lee 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.
- Background: PubMed 32075640Genevieve 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.
- Background: PubMed 33037017Awasthi 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.
- Background: PubMed 28770442Bentley 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.
- Background: PubMed 19622575O'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.
- National Cancer Institute. Cancer statistics (2018)Link provided by the sponsor.
- National Cancer Institute. Cancer types (2018)Link provided by the sponsor.
- Jessica Kent. Health Affairs. Accessed December 25, 2020Link provided by the sponsor.
- Giorgio Sirugo et al, The Missing Diversity in Human Genetic Studies. Cell. Accessed December 25, 2020Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Ovarian Cancer, run by Labcorp Corporation of America Holdings, Inc at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697198, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.