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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03544255
• Other study ID #: EFOP-01
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: January 2020
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Shu Zhang, PhD
• Phone: +86 13770728926
• Email: zhangshu19900513[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Biopsy
Two extra EUS-FNA guided pancreatic biopsies collected for only research purposes.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Ying Lv

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of organoids successfully generated from pancreatic cancer biopsies	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.	09/01/2018-06/01/2019
Secondary	Response of the pancreatic cancer organoids to the selected anti-cancer drugs	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).	06/01/2019-06/01/2020