Concept and feasibility of the Augsburg longitudinal plasma study (ALPS) - a prospective trial for comprehensive liquid biopsy-based longitudinal monitoring of solid cancer patients

  • Objectives Liquid biopsy (LBx) provides diagnostic, prognostic and predictive insights for malignant diseases and offers promising applications regarding tumor burden, tumor heterogeneity and clonal evolution. Methods ALPS is a prospective trial for patients with metastatic cancer that comprises sequential collection of LBx samples, tumor tissue, radiological imaging data, clinical information and patient-reported outcomes. Peripheral blood plasma is collected based on the individual patient’s staging intervals and LBx-derived ctDNA analyses are performed using CAncer Personalized Profiling sequencing (CAPP-seq). Results From April 2021 to October 2023, 419 patients have been enrolled. A total of 1,293 LBx samples were collected, 419 samples (100 %) at the beginning of the study and an average of 3 (range 1–12) during the 30-month follow-up period of the current interim analysis. 380 tissue biopsy (TBx) samples (90.7 %) were available at baseline and 39.6 % had ≥1 TBx samplesObjectives Liquid biopsy (LBx) provides diagnostic, prognostic and predictive insights for malignant diseases and offers promising applications regarding tumor burden, tumor heterogeneity and clonal evolution. Methods ALPS is a prospective trial for patients with metastatic cancer that comprises sequential collection of LBx samples, tumor tissue, radiological imaging data, clinical information and patient-reported outcomes. Peripheral blood plasma is collected based on the individual patient’s staging intervals and LBx-derived ctDNA analyses are performed using CAncer Personalized Profiling sequencing (CAPP-seq). Results From April 2021 to October 2023, 419 patients have been enrolled. A total of 1,293 LBx samples were collected, 419 samples (100 %) at the beginning of the study and an average of 3 (range 1–12) during the 30-month follow-up period of the current interim analysis. 380 tissue biopsy (TBx) samples (90.7 %) were available at baseline and 39.6 % had ≥1 TBx samples at follow-up. Lung cancer patients are most prevalent in ALPS (n=147), followed by colorectal (n=38), prostate (n=31) and gastroesophageal cancer (n=28). On average, 12.0 ng/mL plasma cell-free DNA (cfDNA) could be isolated. First CAPP-seq analyses in 60 patients comprised 110 samples and demonstrated a detection sensitivity of 0.1 %. Conclusions The first interim analysis of ALPS confirms feasibility for comprehensive longitudinal evaluation of LBx and demonstrates suitability for ctDNA evaluation.show moreshow less

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Metadaten
Author:Sebastian Sommer, Maximilian Schmutz, Kathrin Hildebrand, Annett Schiwitza, Selinah Benedikt, Maria Eberle, Tatiana Mögele, Aziz Sultan, Lena Reichl, Maria Campillo, Luise Uhrmacher, Ana Antic Nikolic, Ralph Bundschuh, Constantin LapaORCiDGND, Michaela KuhlenGND, Sebastian DintnerGND, Angela Langer, Bruno MärklORCiDGND, Thomas Wendler, Kartikay Tehlan, Thomas KrönckeORCiDGND, Maria Wahle, Matthias Mann, Nicolas Casadei, Michaela Pogoda, Simone Hummler, Irmengard Sax, Matthias SchlesnerORCiDGND, Boris Kubuschok, Martin TrepelGND, Rainer ClausGND
Frontdoor URLhttps://opus.bibliothek.uni-augsburg.de/opus4/112855
ISSN:2567-9430OPAC
ISSN:2567-9449OPAC
Parent Title (English):Journal of Laboratory Medicine
Publisher:Walter de Gruyter
Place of publication:Berlin
Type:Article
Language:English
Year of first Publication:2024
Publishing Institution:Universität Augsburg
Release Date:2024/05/10
DOI:https://doi.org/10.1515/labmed-2023-0156
Institutes:Fakultät für Angewandte Informatik
Fakultät für Angewandte Informatik / Institut für Informatik
Medizinische Fakultät
Fakultät für Angewandte Informatik / Institut für Informatik / Lehrstuhl für Biomedizinische Informatik, Data Mining und Data Analytics
Medizinische Fakultät / Universitätsklinikum
Medizinische Fakultät / Lehrstuhl für Allgemeine und Spezielle Pathologie
Medizinische Fakultät / Lehrstuhl für Diagnostische und Interventionelle Radiologie
Medizinische Fakultät / Lehrstuhl für Innere Medizin mit Schwerpunkt Hämatologie und Onkologie
Medizinische Fakultät / Lehrstuhl für Kinder- und Jugendmedizin
Medizinische Fakultät / Lehrstuhl für Nuklearmedizin
Medizinische Fakultät / Professur für personalisierte Tumormedizin und molekulare Onkologie
Medizinische Fakultät / Professur für Clinical Computational Medical Imaging Research
Dewey Decimal Classification:0 Informatik, Informationswissenschaft, allgemeine Werke / 00 Informatik, Wissen, Systeme / 004 Datenverarbeitung; Informatik
6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Latest Publications (not yet published in print):Aktuelle Publikationen (noch nicht gedruckt erschienen)
Licence (German):CC-BY 4.0: Creative Commons: Namensnennung (mit Print on Demand)