The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test into Clinical Practice
| Autor: | Richard Whittington, Margarita Lopatin, Geoffrey R. Oxnard, Catherine R. Marinac, Bruce Taylor, Eric A. Klein, Eric T. Fung, Charles H. McDonnell, Lincoln Nadauld, Deborah Schrag, Andrew G. Hudnut, Jafi A. Lipson, Tomasz M. Beer, Karen C. Chung, Rita Shaknovich, Minetta C. Liu |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Article 03 medical and health sciences 0302 clinical medicine Internal medicine medicine cancer 030212 general & internal medicine multi-cancer early detection test RC254-282 business.industry methylation cell-free DNA Cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens Cancer Early Detection medicine.disease Plasma.cfDNA Test (assessment) Clinical Practice Pathfinder 030220 oncology & carcinogenesis Cohort Test performance diagnostic pathways business |
| Zdroj: | Cancers, Vol 13, Iss 3501, p 3501 (2021) Cancers Volume 13 Issue 14 |
| ISSN: | 2072-6694 |
| Popis: | To examine the extent of the evaluation required to achieve diagnostic resolution and the test performance characteristics of a targeted methylation cell-free DNA (cfDNA)-based multi-cancer early detection (MCED) test, ~6200 participants ≥50 years with (cohort A) or without (cohort B) ≥1 of 3 additional specific cancer risk factors will be enrolled in PATHFINDER (NCT04241796), a prospective, longitudinal, interventional, multi-center study. Plasma cfDNA from blood samples will be analyzed to detect abnormally methylated DNA associated with cancer (i.e., cancer “signal”) and a cancer signal origin (i.e., tissue of origin). Participants with a “signal detected” will undergo further diagnostic evaluation per guiding physician discretion those with a “signal not detected” will be advised to continue guideline-recommended screening. The primary objective will be to assess the number and types of subsequent diagnostic tests needed for diagnostic resolution. Based on microsimulations (using estimates of cancer incidence and dwell times) of the typical risk profiles of anticipated participants, the median (95% CI) number of participants with a “signal detected” result is expected to be 106 (87–128). Subsequent diagnostic evaluation is expected to detect 52 (39–67) cancers. The positive predictive value of the MCED test is expected to be 49% (39–58%). PATHFINDER will evaluate the integration of a cfDNA-based MCED test into existing clinical cancer diagnostic pathways. The study design of PATHFINDER is described here. |
| Databáze: | OpenAIRE |
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