NGS And TME For Evidence-based Treatment Of Pancreatic Cancer

Study Overview

NGS and TME for Evidence-based Treatment of 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.

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.

Pancreatic Ductal Adenocarcinoma

GENETIC: NGS

PePaCaKa-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-03-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-10-22
First Submitted that Met QC Criteria 2016-05-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-10-24
First Posted (ACTUAL) 2016-05-10	Results First Posted N/A	Last Verified 2023-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

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

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Johan Permert, MD PhD, Karolinska University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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.

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Resources

PatientS

Caregivers

Clinical Trial Record