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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03544255
Other study ID # EFOP-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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