1. Correlation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis (Time Frame - through study completion, an average of 3 years): Correlation of tumor mutations between TBx and LBx at diagnosis with TBx as reference method based on PPA (positive percent agreement) and NPA (negative percent agreement)
2. Concordance between TBx and LBx at disease progression (Time Frame - from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months): Concordance between TBx and LBx at disease progression with TBx as reference method based on PPA (positive percent agreement) and NPA (negative percent agreement)
Secondary outcome:
1. Investigation of tumor heterogeneity as a prognostic marker (Time Frame - through study completion, an average of 3 years): Correlation of known and potential oncogenic drivers with imaging modalities based on morphological therapeutic response: ORR in classical entities and pools of tumor entities with ≥ 40 patient sample size
2. Correlation of known and potential oncogenic drivers in LBx with DCR (Time Frame - through study completion, an average of 3 years): Correlation of known and potential oncogenic drivers with imaging modalities based on morphological therapeutic response: DCR in classical entities and pools of tumor entities with ≥ 40 patient sample size
3. Correlation of known and potential oncogenic drivers in LBx with OS (Time Frame - through study completion, an average of 3 years): Correlation of presence of known and potential oncogenic drivers in LBx with OS per classical tumor entities and pools of tumor entities with ≥ 100 patient sample size
4. Role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity (Time Frame - through study completion, an average of 3 years): to evaluate the role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool."
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