Cross-Platform Biomarker Program for Establishment and Validation of Liquid Biopsy for Clinical Decision Making in resectable gastrointestinal stromal tumour (GIST)
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ABSTRACT: Interventions: Group 1: Day -30 to -1 prior to start of therapy: Screening examination for all participants. A mutational analysis of a histologic sample is performed to detect cKIT- and PDGFR-mutations (inclusion criteria). Additionally imaging methods according to local standards are performed, blood samples will be taken and participants registered.
Participants with cKIT- and/or PDGFR-mutated tumours are further included:
During neoadjuvant therapy and during surgical therapy:
Day -1 to 0: Blood taking for ctDNA and proteins
Day +6 (±2): Blood taking for ctDNA and proteins
Day +14 (±2): Blood taking for ctDNA and proteins
After surgical therapy:
Month +3 to +60, every three months (± 28 d): imaging, blood taking for ctDNA and proteins
The current medication and disease stage is ascertained at every visit. The taken blood volume is 63 mL each.
Primary outcome(s): 1. detection of tumor-specific mutations in ctDNA isolated from plasma after surgical therapy
Study Design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: Prognosis
DISEASE(S): Malignant Neoplasm Of Oesophagus,Malignant Neoplasm Of Small Intestine,Malignant Neoplasm Of Retroperitoneum And Peritoneum,Malignant Neoplasm Of Stomach,Malignant Neoplasm Of Colon
PROVIDER: 2437894 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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