NCT02767700

NGS and TME for Evidence-based Treatment of Pancreatic Cancer

Evaluation of NGS in Combination With an Oncology Treatment Decision Support Software for Evidence-based Priorization of Individualised Treatment in Patients With Pancreatic Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
GENETIC	NGS	Next generation sequencing

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-03-25
• Completion: 2018-08-31
• First posted: 2016-05-10
• Last updated: 2023-10-24