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Trial record 5 of 2832 for:    Pancreatic Cancer

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

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ClinicalTrials.gov Identifier: NCT03544255
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ying Lv, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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
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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Number of organoids successfully generated from pancreatic cancer biopsies [ Time Frame: 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 [ Time Frame: 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).


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suspected to have pancreatic cancer who are going to receive EUS-FNA operations for diagnostic purposes.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544255


Contacts
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Contact: Shu Zhang, PhD +86 13770728926 zhangshu19900513@126.com

Locations
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China, Jiangsu
Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Guangshu Han         
Sponsors and Collaborators
Ying Lv
Investigators
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Principal Investigator: Ying Lv, PhD The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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Responsible Party: Ying Lv, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03544255     History of Changes
Other Study ID Numbers: EFOP-01
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ying Lv, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
pancreatic cancer
EUS-FNA
organoid

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases