Drug Screening of Pancreatic Cancer Organoids Developed From EUS-FNA Guided Biopsy Tissues

• Conditions: Pancreas Adenocarcinoma; Pancreatic Cancer

• Registration Number: NCT03544255
• Lead Sponsor: Ying Lv

Brief Summary

We are going to establish "organoid" models from pancreatic cancer biopsies achieved via EUS-FNA. Then the sensitivity of the selected FDA-approved anti-cancer drugs will be tested in these organoids.

Detailed Description

The survival rate of pancreatic cancer, a kind of malignant tumor, remains poor due to lack of effective treatments. Recently, a new model called "organoid" has been generated from human and murine pancreatic cancer tissues. These organoids are developed from large pieces of surgical tissues or small biopsies taken from EUS-FNA guided samples. Here in our study we are going to establish "organoid" models from pancreatic cancer biopsies achieved via EUS-FNA. After successful generation of these organoids, we will treat them with the selected FDA-approved anti-cancer drugs, and assess the responses to these anti-cancer agents in our established organoids.

Study Timeline

• Study First Submitted: 2018-04-17
• Study Start: 2018-05-01
• Study First Submitted QC: 2018-05-21
• Study First Posted: 2018-06-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-05
• Last Update Posted: 2020-01-07
• Primary Completion: 2020-12-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

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

Inclusion Criteria

• 1. Patients suspected to have pancreatic cancer who will receive EUS-FNA for diagnosis; 2) Patients who have signed the informed consent.

Exclusion Criteria

• 1. Those who are under the age of 18; 2) Patients who have received adjuvant chemoradiotherapies or other anti-tumor therapies; 3) Patients with critical illness and cannot tolerate the operations; 4) Women who have been pregnant or are planning to be pregnant.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of organoids successfully generated from pancreatic cancer biopsies	09/01/2018-06/01/2019	Successful isolation of pancreatic cancer organoids within 2 weeks of EUS-FNA operation will be defined as successful establishment of an organoid. We will calculate the total number of organoids generated in our center.

Secondary Outcome Measures

Name	Time	Method
Response of the pancreatic cancer organoids to the selected anti-cancer drugs	06/01/2019-06/01/2020	We will treat the established organoids with the selected FDA-approved drugs. Then the anti-cancer activity of these drugs will be tested using CellTiter-Glo 3D Cell Viability Assay (Promega).

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China