Patient-derived Organoids Drug Screen in Pancreatic Cancer

Not Applicable

Recruiting

• Conditions: Pancreas Cancer; Pancreas Neoplasm; Pancreatic Adenocarcinoma; Pancreas Adenocarcinoma; Pancreatic Cancer; Pancreatic Neoplasms
• Interventions: Procedure: Surgical biopsy of tumoral tissue for organoid generation

• Registration Number: NCT05351983
• Lead Sponsor: Prof. Dr. med. Dres. h.c. Jan Schmidt, MME

Brief Summary

Few chemotherapeutic options exist for pancreatic cancer. Moreover, objective criteria are lacking for deciding which regimen is more beneficial for patient presenting with metastases at diagnosis.

This study investigates whether organoid generation from tumour samples of pancreatic cancer is a safe and feasible process for testing of multiple chemotherapy regimens in the laboratory.

By participating to this study, patients will have a part of the tumour tissue retrieved and sent to the laboratory for organoid generation and drug testing. For surgically-resectable tumors, tumoral tissue samples will be collected from the main surgical specimens, before sending it for final pathological examination. In case of suspected metastatic lesion at diagnosis, curative surgery is not indicated. Therefore, we will offer patients to undergo port-a-cath implantation for chemotherapy delivery and concomitant laparoscopic surgical excisional biopsy of suspicious metastatic (either hepatic or peritoneal) lesions.

At this stage of the study, the treatment that the patient will receive after surgery will not be affected by the results of the laboratory testing. In fact, all patients will receive the standard of care treatment based on the most recent oncologic guidelines and on the oncologist's clinical judgement. As part of the study, each patient will be followed for 30 days to assess possible surgical complications related to the surgical biopsy.

This study will help to speed up the implementation of organoid generation in the clinical routine for the choice of the best treatment of patients affected by pancreatic cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-28
• Study Start: 2022-09-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-25
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Organoid generation	Surgical biopsy of tumoral tissue for organoid generation	All patients will included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation.

Primary Outcome Measures

Name	Time	Method
Feasibility of the process	30 days after the last patient enrollment.	To determine the proportion of patients (specifically, the percentage with respect to the total sample enrolled in the study) for which organoids can be successfully generated and in which an effective treatment can be identified by drug screens in these patient-derived organoids. Successful generation of organoids will be defined as the presence of individual three-dimensional structures within 10 days from the begin of generation process. Effective treatment is considered a treatment decreasing of 50% (or more) the viability of patient-derived organoids.

Secondary Outcome Measures

Name	Time	Method
Safety of surgical biopsy and post-operative surgical complications.	30 days post-operatively	To evaluate safety of surgical biopsy for patient-derived organoids generation in patients with pancreatic cancer. Safety will be evaluated in terms of absolute and relative (%) number of postoperative complications. Severity will be graded according the Clavien-Dindo classification for surgical complications: complications equal to or greater than grade 3B will be considered as "severe". Management of each complication will be recorded for descriptive purposes.
Chemosensitivity testing	6 days after the last organoid generation	To assess in vitro efficacy of different chemotherapeutic regimens (and their combinations). In vitro efficacy will be evaluated based on the drug's (or drug combination's) capacity to decrease organoid viability of more than 50% after 6 days from their administration. Drugs (or their combination) tested in vitro will include Oxaliplatin, Carboplatin, Cisplatin, SN-38 (Irinotecan), Leucovorin, 5-FU, Gemcitabine, Olaparib, Nab-Paclitaxel, Nanoliposomal irinotecan (Nal-IRI), Niraparib.
Contamination rates	30 days after the last patient enrollment.	To assess the rate of contaminated samples by endogenous bacterial and fungal flora and to highlight possible implications in patient-derived organoid testing response.

Trial Locations

Locations (1)

Hirslanden Kliniks; 🇨🇭 Zürich, Switzerland