Accurate Screening for Early-Stage Breast Cancer by Detection and Profiling of Circulating Tumor Cells.
breast cancer
circulating tumor cells
immunocytochemistry
screening
Journal
Cancers
ISSN: 2072-6694
Titre abrégé: Cancers (Basel)
Pays: Switzerland
ID NLM: 101526829
Informations de publication
Date de publication:
09 Jul 2022
09 Jul 2022
Historique:
received:
24
05
2022
revised:
04
07
2022
accepted:
07
07
2022
entrez:
27
7
2022
pubmed:
28
7
2022
medline:
28
7
2022
Statut:
epublish
Résumé
The early detection of breast cancer (BrC) is associated with improved survival. We describe a blood-based breast cancer detection test based on functional enrichment of breast-adenocarcinoma-associated circulating tumor cells (BrAD-CTCs) and their identification via multiplexed fluorescence immunocytochemistry (ICC) profiling for GCDFP15, GATA3, EpCAM, PanCK, and CD45 status. The ability of the test to differentiate BrC cases ( The test accurately detects BrAD-CTCs in breast cancers, irrespective of age, ethnicity, disease stage, grade, or hormone receptor status. Analytical validation established the high accuracy and reliability of the test under intended use conditions. The test detects and differentiates BrC cases from healthy women with 100% specificity and 92.07% overall sensitivity in a case-control study. In a prospective clinical study, the test shows 93.1% specificity and 94.64% overall sensitivity in differentiating breast cancer cases ( The findings reported in this manuscript support the clinical potential of this test for blood-based BrC detection.
Sections du résumé
BACKGROUND
BACKGROUND
The early detection of breast cancer (BrC) is associated with improved survival. We describe a blood-based breast cancer detection test based on functional enrichment of breast-adenocarcinoma-associated circulating tumor cells (BrAD-CTCs) and their identification via multiplexed fluorescence immunocytochemistry (ICC) profiling for GCDFP15, GATA3, EpCAM, PanCK, and CD45 status.
METHODS
METHODS
The ability of the test to differentiate BrC cases (
RESULTS
RESULTS
The test accurately detects BrAD-CTCs in breast cancers, irrespective of age, ethnicity, disease stage, grade, or hormone receptor status. Analytical validation established the high accuracy and reliability of the test under intended use conditions. The test detects and differentiates BrC cases from healthy women with 100% specificity and 92.07% overall sensitivity in a case-control study. In a prospective clinical study, the test shows 93.1% specificity and 94.64% overall sensitivity in differentiating breast cancer cases (
CONCLUSION
CONCLUSIONS
The findings reported in this manuscript support the clinical potential of this test for blood-based BrC detection.
Identifiants
pubmed: 35884402
pii: cancers14143341
doi: 10.3390/cancers14143341
pmc: PMC9316476
pii:
doi:
Types de publication
Journal Article
Langues
eng
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