Clinical trial · Observational
PRospective REgistry of Advanced Stage CancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations to Address Disparities in Precision Medicine
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
NCT05697198CI-TRIAL-00086855PREFERcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OmniSeq Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- label
- Cohort lung cancer
- interventionNames
- Diagnostic Test: OmniSeq Test
- label
- Gyn malignancies
- interventionNames
- Diagnostic Test: OmniSeq Test
- label
- Gastrointestinal malignancies Cohort
- interventionNames
- Diagnostic Test: OmniSeq Test
- label
- Melanoma Cohort
- interventionNames
- Diagnostic Test: OmniSeq Test
- label
- Breast cancer Cohort
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDAlizadeh 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. PMID 10676951
- BACKGROUNDGuinney 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. PMID 26457759
- BACKGROUNDPerou 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. PMID 10963602
- BACKGROUNDDavies 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. PMID 12068308