Genomic profiling and expanded use of targeted anticancer drugs in solid cancers with exhausted evidence-based treatment options (PRECODE): study protocol of a prospective, non-randomized, cohort study.

Autor: Hansen KH; Department of Oncology, Odense University Hospital, Odense, Denmark. holmskov-hansen@hotmail.com., Lyng MB; Department of Pathology, Odense University Hospital, Odense, Denmark., Kodahl AR; Department of Oncology, Odense University Hospital, Odense, Denmark.; Department of Clinical Research, University of Southern Denmark, Odense, Denmark., Asmussen JT; Department of Radiology, Odense University Hospital, Odense, Denmark., Arshad A; Department of Respiratory Medicine, Odense University Hospital, Odense, Denmark., Petersen H; Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark., Krogh L; Department of Clinical Genetics, Odense University Hospital, Odense, Denmark., Ehmsen S; Department of Oncology, Odense University Hospital, Odense, Denmark.; Department of Clinical Research, University of Southern Denmark, Odense, Denmark., Kristensen TK; Department of Pathology, Odense University Hospital, Odense, Denmark.; Clinical Development, Odense University Hospital, Odense, Denmark., Ditzel HJ; Department of Oncology, Odense University Hospital, Odense, Denmark.; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Jazyk: angličtina
Zdroj: BMC medical genomics [BMC Med Genomics] 2024 Nov 21; Vol. 17 (1), pp. 274. Date of Electronic Publication: 2024 Nov 21.
DOI: 10.1186/s12920-024-02033-z
Abstrakt: Background: Genomic profiling of advanced solid cancer in patients with no further evidence based standard treatment options is a novel approach to identify potential experimental treatment options based on specific genomic alterations. Due to the expected short survival of these patients timely assessment of potential druggable targets is critical to minimize the risk of deterioration during the analysis. The primary objective of this prospective study is to evaluate the turnaround time for genomic profiling and the clinical investigational procedures. The secondary objectives are to investigate how often genomic alterations in tumor tissue gives rise to a matched treatment offer and evaluate the clinical outcome.
Methods: The PRECODE study is a prospective, non-randomized, single-center cohort study conducted at Departments of Oncology and Pathology, Odense University Hospital, Denmark. Enrollment between March 1, 2019 and December 31, 2024. Eligibility criteria are age ≥ 18 years, written informed consent, advanced solid tumors, exhausted treatment options, ECOG performance status 0-2, adequate organ function and life expectancy ≥ 3 months. A core needle biopsy is analyzed by next generation sequencing using a pan-cancer comprehensive panel. Results are discussed weekly at institutional/local and national multidisciplinary tumor boards.
Discussion: Strategies and methods for genomic profiling of advanced solid cancers differ. Rapid analysis and interpretation of sequencing data are key to avoiding delays in initiation potential experimental treatments, as these late-stage patients may quickly deteriorate. Although a highly optimized setup with fast-track clinical evaluation and genomic profiling has been established a subset will not be offered a targeted treatment due to deterioration. Local and national multidisciplinary teams have been established to optimize individualized treatment decisions. After genomic profiling a subset of patients will take part in clinical trials, which will constrain the reporting of overall survival or progression free survival.
Trial Registration: Danish Ethics Committee, Projekt-ID: S-2018014, date of approval: 27- FEB- 2019) Danish Data Protection Agency (Journal no: 18/58329, date of approval: 23-NOV-2018).
Clinicaltrials: gov Identifier: NCT05385081 (retrospectively registered).
Competing Interests: Declarations. Ethics approval and consent to participate: The study was approved by the Regional Ethics Committee (Danish Ethics Committee, Projekt-ID: S-2018014, date of approval: 27- FEB- 2019) and the Danish Data Protection Agency (Journal no: 18/58329, date of approval: 23-NOV-2018). Protocol amendments and modifications are submitted to the appropriate authorities for approval. All patients provides signed informed consent. The study is conducted according to the international standards of IHC/Good Clinical Practice and in accordance with the Declaration of Helsinki. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.
(© 2024. The Author(s).)
Databáze: MEDLINE
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