NCT03500068: OPT-1

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

Status unknown NA Last updated 19 January 2021

What this trial tests

NA trial testing biopsies & blood analyses in Carcinoma, Pancreatic Ductal in 30 participants. Status unknown.

Timeline

4 September 2017

Primary endpoint
1 September 2022

1 September 2022

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	30
Start date	4 September 2017
Primary completion	1 September 2022
Estimated completion	1 September 2022
Sites	1 location across Netherlands

Drugs / interventions tested

• biopsies & blood analyses

Conditions studied

• Carcinoma, Pancreatic Ductal — all drugs for Carcinoma, Pancreatic Ductal →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Pancreatic Ductal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient-Derived Organoids in Precision Medicine: Drug Screening, Organoid-on-a-Chip and Living Organoid Biobank.
   Zhou Z, Cong L, Cong X. · · 2021 · cited 112× · PMID 35036354 · DOI 10.3389/fonc.2021.762184
2. Patient-derived tumor organoids: a new avenue for preclinical research and precision medicine in oncology.
   Thorel L, Perréard M, Florent R, Divoux J, et al · · 2024 · cited 90× · PMID 38945959 · DOI 10.1038/s12276-024-01272-5
3. Applications of human organoids in the personalized treatment for digestive diseases.
   Wang Q, Guo F, Jin Y, Ma Y. · · 2022 · cited 43× · PMID 36167824 · DOI 10.1038/s41392-022-01194-6
4. Patient-derived organoids and high grade serous ovarian cancer: from disease modeling to personalized medicine.
   Nero C, Vizzielli G, Lorusso D, Cesari E, et al · · 2021 · cited 42× · PMID 33789687 · DOI 10.1186/s13046-021-01917-7
5. Patient-Derived Tumor Organoids for Drug Repositioning in Cancer Care: A Promising Approach in the Era of Tailored Treatment.
   Vivarelli S, Candido S, Caruso G, Falzone L, et al · · 2020 · cited 29× · PMID 33291603 · DOI 10.3390/cancers12123636
6. Tumour organoids and assembloids: Patient-derived cancer avatars for immunotherapy.
   Mei J, Liu X, Tian HX, Chen Y, et al · · 2024 · cited 25× · PMID 38664597 · DOI 10.1002/ctm2.1656
7. Pancreatic Cancer Patient-Derived Organoid Platforms: A Clinical Tool to Study Cell- and Non-Cell-Autonomous Mechanisms of Treatment Response.
   Piro G, Agostini A, Larghi A, Quero G, et al · · 2021 · cited 19× · PMID 35004765 · DOI 10.3389/fmed.2021.793144
8. Organoid-based precision medicine in pancreatic cancer.
   Beutel AK, Ekizce M, Ettrich TJ, Seufferlein T, et al · · 2025 · cited 9× · PMID 39540683 · DOI 10.1002/ueg2.12701