Pancreatic CancerNCT03544255
Drug Screening of Pancreatic Cancer Organoids Developed From EUS-FNA Guided Biopsy Tissues
An observational study of Pancreatic Cancer and Pancreas Adenocarcinoma, run by Ying Lv at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreas Adenocarcinoma
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suspected to have pancreatic cancer who are going to receive EUS-FNA operations for diagnostic purposes.
Who may be able to join
- 1) Patients suspected to have pancreatic cancer who will receive EUS-FNA for diagnosis; 2) Patients who have signed the informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Guangshu Han
About this study
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Pancreas Adenocarcinoma
- Being tested
- Biopsy
- Keywords
- pancreatic cancer, EUS-FNA, organoid
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Two extra EUS-FNA guided pancreatic biopsies collected for only research purposes.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 09/01/2018-06/01/2019
Secondary outcomes (1)
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).
Measured: 06/01/2019-06/01/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 May 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Lv
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ying Lv, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Ying Lv, PhD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544255
- Sponsor's protocol ID
- EFOP-01
- Status last verified
- Jan 2020
- First submitted
- 17 Apr 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Screening of Pancreatic Cancer Organoids Developed From EUS-FNA Guided Biopsy Tissues
- ClinicalTrials.gov ID
- NCT03544255
- Acronym / sponsor ID
- EFOP-01
- Conditions
- Pancreatic Cancer, Pancreas Adenocarcinoma
- Keywords
- pancreatic cancer, EUS-FNA, organoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ying LvUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected to have pancreatic cancer who are going to receive EUS-FNA operations for diagnostic purposes.
Key inclusion criteria (1 listed)
- 1) Patients suspected to have pancreatic cancer who will receive EUS-FNA for diagnosis; 2) Patients who have signed the informed consent.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyTwo extra EUS-FNA guided pancreatic biopsies collected for only research purposes. | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
Response of the pancreatic cancer organoids to the selected anti-cancer drugs
Time frame: 06/01/2019-06/01/2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Lv, PhD principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Pancreas Adenocarcinoma, run by Ying Lv at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu Zhang, PhD (+86 13770728926, zhangshu19900513@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of organoids successfully generated from pancreatic cancer biopsies (time frame: 09/01/2018-06/01/2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.