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

• Sponsor: Ying Lv (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03544255
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer; Pancreas Adenocarcinoma	Procedure: Biopsy

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Drug Screening of Pancreatic Cancer Organoids Developed From EUS-FNA Guided Biopsy Tissues
• Actual Study Start Date: May 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Jun 1, 2021

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008

Sponsors and Collaborators

• Ying Lv

Investigators

• Principal Investigator: Ying Lv, PhD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ying Lv, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• ClinicalTrials.gov Identifier: NCT03544255
• Other Study ID Numbers: EFOP-01
• First Posted: Jun 1, 2018
• Last Update Posted: Jan 7, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ying Lv, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: pancreatic cancer; EUS-FNA; organoid
• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

No Results Posted as of Jan 7, 2020