Identification of minimal residual disease using the clonesight test for ultrasensitive ctDNA detection to anticipate late relapse in early breast cancer

Abstract Background Early-stage breast cancer (BC) diagnosis significantly reduces mortality, yet relapse remains a concern due to undetectable minimal residual disease (MRD). Liquid biopsies offer real-time insights into tumor dynamics, aiding MRD detection and therapy response evaluation. However,...

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Main Authors: Iñaki Comino-Méndez, Jesús Velasco-Suelto, Javier Pascual, Esperanza López-López, Maria Elena Quirós-Ortega, Celia Gaona-Romero, Alejandro Martín-Muñoz, Patricia Losana, Yanira Heredia, Emilio Alba, Angel Guerrero-Zotano
Format: Article
Language:English
Published: BMC 2025-05-01
Series:Breast Cancer Research
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Online Access:https://doi.org/10.1186/s13058-025-02016-7
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author Iñaki Comino-Méndez
Jesús Velasco-Suelto
Javier Pascual
Esperanza López-López
Maria Elena Quirós-Ortega
Celia Gaona-Romero
Alejandro Martín-Muñoz
Patricia Losana
Yanira Heredia
Emilio Alba
Angel Guerrero-Zotano
author_facet Iñaki Comino-Méndez
Jesús Velasco-Suelto
Javier Pascual
Esperanza López-López
Maria Elena Quirós-Ortega
Celia Gaona-Romero
Alejandro Martín-Muñoz
Patricia Losana
Yanira Heredia
Emilio Alba
Angel Guerrero-Zotano
author_sort Iñaki Comino-Méndez
collection DOAJ
description Abstract Background Early-stage breast cancer (BC) diagnosis significantly reduces mortality, yet relapse remains a concern due to undetectable minimal residual disease (MRD). Liquid biopsies offer real-time insights into tumor dynamics, aiding MRD detection and therapy response evaluation. However, MRD detection is challenging due to low tumor DNA levels in circulation. Methods This prospective study included 20 HR + BC patients who had completed at least 5 years of adjuvant endocrine therapy (ET). Plasma samples were collected every 6 months over a median follow-up period of 2 years. Tumor-specific somatic variants identified through tumor tissue sequencing served as biomarkers for a patient-informed circulating tumor DNA (ctDNA) assay (CloneSight), which utilized a multiplex PCR-based next-generation sequencing (NGS) workflow. Results ctDNA was detected in patients who experienced clinical relapse, with positivity observed up to 68 months (5.7 years) prior to overt recurrence, highlighting its potential for early relapse identification. In non-relapsed patients, ctDNA remained undetectable in 93% of cases, reflecting a potential high level of specificity. The assay detected ctDNA in 50% of relapsed patients, while no ctDNA signal was identified in the majority of non-relapsed cases. Conclusion Our exploratory findings indicate that CloneSight could be a promising tool for MRD detection and relapse prediction, providing a cost-effective, patient-informed approach to ctDNA monitoring. The ability of this approach to detect relapse prior to clinical recurrence suggests its potential relevance in improving patient monitoring. These findings suggest that ctDNA-based MRD assays could play a role in future surveillance strategies for HR + BC, though further studies in larger cohorts are needed to confirm their clinical applicability.
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spelling doaj-art-ced1e1029dde4ace8d9fddee67d4eb052025-08-20T03:52:28ZengBMCBreast Cancer Research1465-542X2025-05-0127111010.1186/s13058-025-02016-7Identification of minimal residual disease using the clonesight test for ultrasensitive ctDNA detection to anticipate late relapse in early breast cancerIñaki Comino-Méndez0Jesús Velasco-Suelto1Javier Pascual2Esperanza López-López3Maria Elena Quirós-Ortega4Celia Gaona-Romero5Alejandro Martín-Muñoz6Patricia Losana7Yanira Heredia8Emilio Alba9Angel Guerrero-Zotano10Medical Oncology Department, Hospital Universitario Virgen de la VictoriaMedical Oncology Department, Hospital Universitario Virgen de la VictoriaMedical Oncology Department, Hospital Universitario Virgen de la VictoriaMedical Oncology Department, Hospital Universitario Virgen de la VictoriaMedical Oncology Department, Hospital Universitario Virgen de la VictoriaMedical Oncology Department, Hospital Universitario Virgen de la VictoriaHematological Malignancies Clinical Research Unit, Centro Nacional de Investigaciones Oncologicas (CNIO)Altum Sequencing CoAltum Sequencing CoMedical Oncology Department, Hospital Universitario Virgen de la VictoriaMedical Oncology Department, Fundación Instituto Valenciano de OncologíaAbstract Background Early-stage breast cancer (BC) diagnosis significantly reduces mortality, yet relapse remains a concern due to undetectable minimal residual disease (MRD). Liquid biopsies offer real-time insights into tumor dynamics, aiding MRD detection and therapy response evaluation. However, MRD detection is challenging due to low tumor DNA levels in circulation. Methods This prospective study included 20 HR + BC patients who had completed at least 5 years of adjuvant endocrine therapy (ET). Plasma samples were collected every 6 months over a median follow-up period of 2 years. Tumor-specific somatic variants identified through tumor tissue sequencing served as biomarkers for a patient-informed circulating tumor DNA (ctDNA) assay (CloneSight), which utilized a multiplex PCR-based next-generation sequencing (NGS) workflow. Results ctDNA was detected in patients who experienced clinical relapse, with positivity observed up to 68 months (5.7 years) prior to overt recurrence, highlighting its potential for early relapse identification. In non-relapsed patients, ctDNA remained undetectable in 93% of cases, reflecting a potential high level of specificity. The assay detected ctDNA in 50% of relapsed patients, while no ctDNA signal was identified in the majority of non-relapsed cases. Conclusion Our exploratory findings indicate that CloneSight could be a promising tool for MRD detection and relapse prediction, providing a cost-effective, patient-informed approach to ctDNA monitoring. The ability of this approach to detect relapse prior to clinical recurrence suggests its potential relevance in improving patient monitoring. These findings suggest that ctDNA-based MRD assays could play a role in future surveillance strategies for HR + BC, though further studies in larger cohorts are needed to confirm their clinical applicability.https://doi.org/10.1186/s13058-025-02016-7Liquid biopsyEarly breast cancerCirculating tumor DNAMinimal residual disease
spellingShingle Iñaki Comino-Méndez
Jesús Velasco-Suelto
Javier Pascual
Esperanza López-López
Maria Elena Quirós-Ortega
Celia Gaona-Romero
Alejandro Martín-Muñoz
Patricia Losana
Yanira Heredia
Emilio Alba
Angel Guerrero-Zotano
Identification of minimal residual disease using the clonesight test for ultrasensitive ctDNA detection to anticipate late relapse in early breast cancer
Breast Cancer Research
Liquid biopsy
Early breast cancer
Circulating tumor DNA
Minimal residual disease
title Identification of minimal residual disease using the clonesight test for ultrasensitive ctDNA detection to anticipate late relapse in early breast cancer
title_full Identification of minimal residual disease using the clonesight test for ultrasensitive ctDNA detection to anticipate late relapse in early breast cancer
title_fullStr Identification of minimal residual disease using the clonesight test for ultrasensitive ctDNA detection to anticipate late relapse in early breast cancer
title_full_unstemmed Identification of minimal residual disease using the clonesight test for ultrasensitive ctDNA detection to anticipate late relapse in early breast cancer
title_short Identification of minimal residual disease using the clonesight test for ultrasensitive ctDNA detection to anticipate late relapse in early breast cancer
title_sort identification of minimal residual disease using the clonesight test for ultrasensitive ctdna detection to anticipate late relapse in early breast cancer
topic Liquid biopsy
Early breast cancer
Circulating tumor DNA
Minimal residual disease
url https://doi.org/10.1186/s13058-025-02016-7
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