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Establishing Organoids From Metastatic Pancreatic Cancer Patients, the OPT-I Study. (OPT-1)

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ClinicalTrials.gov Identifier: NCT03500068
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Erasmus Medical Center
Information provided by (Responsible Party):
J.W. Wilmink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Pancreatic Ductal Diagnostic Test: biopsies & blood analyses Not Applicable

Detailed Description:

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.

Objective: To develop a model system and infrastructure to individualize the treatment of patients with advanced pancreatic adenocarcinoma. Additionally, we aim to identify predictors of therapy (non)response.

Study design: Observational laboratory studies (with DNA/RNA isolation, RNA sequencing, cell culturing, organoid culturing and xenografting) will be performed with tumour specimens. These organoids will be stored for future research.

Study population: All adult patients (> 18 years) with (a suspicion of) advanced pancreatic adenocarcinoma

Main study parameters/endpoints: The development of organoids from biopsies of metastases or primary tumour tissue of pancreatic cancer that correlate with clinical response. These models are then analysed for the expression of bio markers in organoid, organotypic and xenograft models. DNA/RNA profiles will be correlated to clinical and pathological characteristics such as therapy response, survival and TNM classification.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participating in this study requires a biopsy from the patient. The material will be obtained from the biopsy required for diagnosis or the patient is asked for consent for an additional tumor biopsy not required for diagnosis. The study could benefit patients as their organoids can be used to assess efficacy of first-line treatment and when necessary may provide an advice for second-line treatment options. Additionally, patients may benefit in the future, if biomarkers are found to predict therapy (non)response.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Establishing Organoids From Metastatic Pancreatic Cancer Patients, the OPT-I Study
Actual Study Start Date : September 4, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: biopsies & blood analyses
    They will take blood and a biopsy from the metastase in the patient


Primary Outcome Measures :
  1. Developing organoids from advanced pancreatic cancer patients that predict non response or response [ Time Frame: 2 months ]

    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.



Secondary Outcome Measures :
  1. Functional studies will be done with the patient derived organoids to find biomarkers that correlate with response in organoids and patients. [ Time Frame: 2 months ]
    Similarly to our primary study parameter, the value of prediction for a biomarker will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500068


Contacts
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Contact: M G van Mackelenbergh 020-5665955 m.g.vanmackelenbergh@amc.nl
Contact: J W Wilmink, M.D. PhD 020-5665955 j.w.wilmink@amc.nl

Locations
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Netherlands
Academic Medical Center, Medical Oncology Recruiting
Amsterdam, Netherlands, 1100 DD
Contact: J. W. Wilmink, MD, PhD, PhD    31 20 5665955    j.w.wilmink@amc.nl   
Contact: Lyda ter Hofstede    31 20 5668229    trialmedonc@amc.uva.nl   
Principal Investigator: H. WM van Laarhoven, MD, PhD, PhD         
Principal Investigator: J. W. Wilmink, M.D., Ph.D.         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center

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Responsible Party: J.W. Wilmink, M.D. PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03500068     History of Changes
Other Study ID Numbers: 2017-202
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by J.W. Wilmink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Pancreatic cancer
Organoids

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary