Pharmacotyping of Pancreatic Patient-derived Organoids
ConditionPancreatic Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHerlev Hospital
About this trial
EUS-FNB samples will be used for organoid cultures, which will be co-cultured with cancer associated fibroblasts derived from the surrounding stroma of the lesion. The organoid cultures will be used for pharmacotyping using relevant chemotherapeutic agents used in the clinic, and the organoid's response compared with the patient's response.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Histopathological confirmation of PDAC and planned standard first-line treatment prior to entering this study OR Patients suspected of primary locally advanced, non-metastatic PDAC based on cross-sectional imaging undergoing diagnostic standard of care (SOC) EUS-FNB procedure
Age > 18 years and older
Life expectancy greater than 3 months
Disqualifiers
Contraindications for nurse administered propofol sedation (NAPS)
Contraindications for EUS-FNB procedure
Trial population
Patients with histopathological confirmation of pancreatic ductal adenocarcimona, ineligible for surgery, planned to start standard first line treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Measurement of organoid's response to therapy
Response of patient derived organoids to standard chemotherapeutic agents used for treatment of patients with pancreatic cancer
Time frame
Organoid co-cultures will be established and pharmacotyped in a timeframe of 2-4 weeks.2
Validation of patient's response to therapy
Computed tomography (CT) scan of the thorax and abdomen are performed at baseline (within 28 days prior to first study drug administration) to assess efficacy of the drugs in patients.
Time frame
3 months follow up3
Comparison between organoid's and patient's response
The response measured in the pharmacoscreen of organoids will be compared with the patient's response
Time frame
4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Herlev Hospital
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Source ClinicalTrials.gov