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

NCT03544255 | Unknown DMC

• 1 other identifier: EFOP-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Pancreas Adenocarcinoma

Keywords

pancreatic cancer; EUS-FNA; organoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Response of the pancreatic cancer organoids to the selected anti-cancer drugs

  06/01/2019-06/01/2020

Interventions

Biopsy PROCEDURE

Two extra EUS-FNA guided pancreatic biopsies collected for only research purposes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suspected to have pancreatic cancer who are going to receive EUS-FNA operations for diagnostic purposes.

You may qualify if:

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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Ying Lv: lead

Study Sites (1)

Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will create organoids from pancreatic cancer biopsies achieved from EUS-FNA. And the pancreatic cancer organoids will be passed and frozen in standard conditions.

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ying Lv, PhD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu Zhang, PhD

CONTACT

+86 13770728926; zhangshu19900513@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: June 1, 2018
• Study Start: May 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

CN (1)