NGS and TME for Evidence-based Treatment of Pancreatic Cancer (PePaCaKa-01)

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Genetic: NGS

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 Type: Observational
• Enrollment (Actual): 39

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with pancreatic adenocarcinoma

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with technical success	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with actionable targets	actionable targets (effective, ineffective, FDA approved toxicity markers)	3 days

Other Outcome Measures

Outcome Measure	Time Frame
Number of patients where NGS+TME generated information was used for treatment	1 week

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Study Chair: Johan Permert, MD PhD, Karolinska University Hospital

Publications and helpful links

General Publications

• Malgerud L, Lindberg J, Wirta V, Gustafsson-Liljefors M, Karimi M, Moro CF, Stecker K, Picker A, Huelsewig C, Stein M, Bohnert R, Del Chiaro M, Haas SL, Heuchel RL, Permert J, Maeurer MJ, Brock S, Verbeke CS, Engstrand L, Jackson DB, Gronberg H, Lohr JM. Bioinformatory-assisted analysis of next-generation sequencing data for precision medicine in pancreatic cancer. Mol Oncol. 2017 Oct;11(10):1413-1429. doi: 10.1002/1878-0261.12108. Epub 2017 Aug 8.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): March 25, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimated): May 10, 2016

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PePaCaKa-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sequencing data will be made available anonymously