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OpenTrials
Completed

NCT Number: NCT02767700

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NGS

Genetic

Next generation sequencing

Primary outcomes

  1. Number of participants with technical success

    Time frame: 2 weeks

Secondary outcomes

  1. Number of participants with actionable targets

    Time frame: 3 days

    actionable targets (effective, ineffective, FDA approved toxicity markers)

Other outcomes

  1. Number of patients where NGS+TME generated information was used for treatment

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 10, 2016
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.