NGS
GeneticNext generation sequencing
NCT Number: NCT02767700
The tumor tissue of patients with pancreatic cancer will be submitted to next-generation sequencing (NGS) and these data will be evaluated with an oncology treatment decision support (TDS) software tool that is a medicinal product class 1 (CE-marked). This software will make evidence-based suggestions for drugs likely to be effective, ineffective, or toxic (FDA approved biomarkers). For patients fit for second-line therapy, the resulting recommendations will be judged by the tumor board.
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Notify Me18 year–75 year
All sexes
Observational
Tumor tissue of patients (surgical resection, biopsy) will be used for SWEDAC-certified DNA extraction and NGS. Pseudonymised sequencing data will be fed into a TDS software tool (TreatmentMAP™, Molecular Health) and based on published evidence, suggestions will be made, graded into NCCN categories of approved drugs in indication or otherwise, clinical evidence or experimental. Same with anticipated inefficacy. In addition, FDA-approved biomarkers for toxicity will be analysed. This information is taken to the tumor board for making a decision whether this information is useful and eventually to recommend a treatment for a given patient.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Next generation sequencing
Time frame: 2 weeks
Time frame: 3 days
actionable targets (effective, ineffective, FDA approved toxicity markers)
Time frame: 1 week
Karolinska University Hospital
Other
Evaluation of NGS in Combination With an Oncology Treatment Decision Support Software for Evidence-based Priorization of Individualised Treatment in Patients With Pancreatic Cancer
Acronym: PePaCaKa-01
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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