NGS and TME for Evidence-based Treatment of Pancreatic Cancer

Completed

• Conditions: Pancreatic Ductal Adenocarcinoma

• Registration Number: NCT02767700
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2016-03-08
• Study Start: 2016-04
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Primary Completion: 2018-03-25
• Study Completion: 2018-08-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-22
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Patient age ≥ 18 years up to 75 years
• Patient willing and able to provide informed consent
• TreatmentMAP™ NGS/TME is ordered by the tumor board (MDT) under routine clinical practice
• Diagnosis of a locally advanced, inoperable or metastatic pancreatic carcinoma, clinically and histologically verified according to the currently prevailing standards.
• Patient received first line therapy according to applicable guidelines and/or standards (SoC)
• Sufficient testing material available (e.g. tumor biopsy) to allow NGS/TME NGS panel testing.

Exclusion Criteria

• Patients with ongoing systemic infection,
• Patients with immunodeficiency,
• Patients with severe cardiovascular and pulmonary morbidity that might interfere with or preclude further systemic anticancer treatment,
• Patients on full therapeutic anticoagulation.
• Patients who, due to their clinical status, are not eligible for further systemic anticancer therapy (chemotherapy, immunotherapy etc.)
• Patients who, due to their disease status are in need of immediate therapy and cannot wait for the result of the NGS/TME process.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with technical success	2 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants with actionable targets	3 days	actionable targets (effective, ineffective, FDA approved toxicity markers)