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Pancreatic Ductal AdenocarcinomaPePaCaKa-01NCT02767700

NGS and TME for Evidence-based Treatment of Pancreatic Cancer

An observational study of Pancreatic Ductal Adenocarcinoma, run by Karolinska University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
NGS
How many people
39 participants
Where
No sites listed yet
Study dates
Apr 2016to 31 Aug 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with pancreatic adenocarcinoma

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official 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

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.

Read the 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.

Being tested
NGS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NGSGenetic

    Next generation sequencing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with technical success

    Measured: 2 weeks

Secondary outcomes (1)

  1. Number of participants with actionable targets

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

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion25 Mar 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02767700
Sponsor's protocol ID
PePaCaKa-01
Acronym
PePaCaKa-01
Status last verified
Oct 2023
First submitted
8 Mar 2016
Last updated
24 Oct 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Sequencing data will be made available anonymously

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.

    PubMed 28675654

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Ductal Adenocarcinoma, run by Karolinska University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with technical success (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02767700, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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