Establishing Organoids From Metastatic Pancreatic Cancer Patients, the OPT-I Study.

NCT03500068 | Unknown DMC

• 1 other identifier: 2017-202
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Pancreatic adenocarcinoma is a malignancy with a poor prognosis. Resection is the only curative option and still 5-year survival rate is less than 10 percent. However, most patients present with advanced disease and are provided with palliative care. The nature of the tumour and the intense stromal reaction around the tumour cells leave pancreatic adenocarcinoma relatively insensitive to chemotherapeutics. Current models, such as cell lines or patient derived xenografts, cannot provide predictive information in a clinically relevant timeframe. Organoids and organotypic culture systems have emerged as promising new culturing techniques that maintain some of the complexity of the tumour. As most patients are ineligible for tumour resection, this project will focus on metastases and will generate organoids from that tissue. Using a combination of organoids and organotypic systems, treatment (non)response can be predicted, which may provide a personalized treatment setting for patients with advanced pancreatic adenocarcinoma.

Conditions

Carcinoma, Pancreatic Ductal

Keywords

Pancreatic cancer; Organoids

Outcome Measures

Primary Outcomes (1)

• Developing organoids from advanced pancreatic cancer patients that predict non response or response

  To assess whether there is a correlation between no response in patients and no response in organoids, a goodness of fit will be determined with Pearson's X2 test. Depending on the available data, the second scenario will be analysed similarly. When organoids cannot be established from biopsy material, then this will be recorded and linked to clinical parameters.

  2 months

Secondary Outcomes (1)

• Functional studies will be done with the patient derived organoids to find biomarkers that correlate with response in organoids and patients.

  2 months

Interventions

biopsies & blood analyses DIAGNOSTIC_TEST

They will take blood and a biopsy from the metastase in the patient

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years
• Diagnosed with locally advanced pancreatic cancer or metastatic pancreatic cancer
• Able to understand the information given
• WHO 0-2

You may not qualify if:

• Unfit for biopsies \& blood analyses
• Not able to give informed consent (language, intellectual capacities, etc.)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Erasmus Medical Center: collaborator

Study Sites (1)

Academic Medical Center, Medical Oncology

Amsterdam, 1100 DD, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal; Pancreatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

M G van Mackelenbergh

CONTACT

020-5665955; m.g.vanmackelenbergh@amc.nl

J W Wilmink, M.D. PhD

CONTACT

020-5665955; j.w.wilmink@amc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PhD

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: September 4, 2017
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)