NGS and TME for Evidence-based Treatment of Pancreatic Cancer

NCT02767700 | Completed DMC

• 1 other identifier: PePaCaKa-01
• Study Type: observational
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with technical success

  2 weeks

Secondary Outcomes (1)

• Number of participants with actionable targets

  3 days

Other Outcomes (1)

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

  1 week

Interventions

NGS GENETIC

Next generation sequencing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pancreatic adenocarcinoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Related Publications (1)

• 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.

  PMID: 28675654 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The study will make use of routinely taken samples (surgical resection, biopsy)

Study Officials

• Johan Permert, MD PhD

  Karolinska University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology & Herpetology

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: May 10, 2016
• Study Start: April 1, 2016
• Primary Completion: March 25, 2018
• Study Completion: August 31, 2018
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share