Pancreas CancerNCT04777604
Development of a Prediction Platform for Neoadjuvant Treatment and Prognosis in Pancreatic Cancer Using Organoid
An observational study of Pancreas Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators create organoid from the pancreatic cancer tissue obtained via EUS-FNA and EUS-FNB within the pancreatic cancer diagnostic process. And also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Organoid
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2021to 7 Jan 2026
- 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: A patient who is in need of neoadjuvant chemotherapy before surgery, having been diagnosed with pancreatic cancer via EUS-FNA and EUS-FNB at Samsung Medical Center. And a patient who is eligible for surgery after neoadjuvantchemotherapy.
Who may be able to join
- 18 years old or older
- Newly discovered pancreatic cancer and not a relapse
- Diagnosed with pancreatic cancer via EUS-FNA, EUS-FNB before surgery
- who is in need of neoadjuvant chemotherapy before surgery
- Patients who can undergo surgery for pancreatic cancer after neoadjuvant chemotherapy
- Diagnosed with pancreatic cancer from the final tissue pathology diagnosis after surgery
- Able to make decisions for oneself for participation
- Has obtained voluntary consent in written form (if 70 years of age or older, receive consent from the guardian as well)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Prediction Platform for Neoadjuvant Treatment and Prognosis in Pancreatic Cancer Using Ex Vivo Analysis of Organoid Culture
The investigators create organoid from the pancreatic cancer tissue obtained via EUS-FNA and EUS-FNB within the pancreatic cancer diagnostic process. And also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. Check for the reactivity to anti-cancer drugs through cell viability assay after treating with various anti-cancer drugs, such as anti-cancer drugs used as neoadjuvant chemotherapy for pancreatic cancer to the organoid. Also, perform genomic analysis on each organoid, and then check if there are any unique genomic mutations for each organoid. By recognizing the relationship between the unique genomic mutations and reactivity to the anti-cancer drug within pancreatic cancer patients eligible for surgery, the investigators aim to strategize appropriate neoadjuvant chemotherapy before surgery, thus developing a platform to predict the outcomes of each patient.
- Conditions
- Pancreas Cancer
- Being tested
- 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.
OrganoidOther
The investigators create organoid from the pancreatic cancer tissue obtained via EUS-FNA and EUS-FNB within the pancreatic cancer diagnostic process. And also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. Check for the reactivity to anti-cancer drugs through cell viability assay after treating with various anti-cancer drugs, such as anti-cancer drugs used as neoadjuvant chemotherapy for pancreatic cancer to the organoid. Also, perform genomic analysis on each organoid, and then check if there are any unique genomic mutations for each organoid. By recognizing the relationship between the unique genomic mutations and reactivity to the anti-cancer drug within patients with resectable pancreatic cancer after neoadjuvant chemotherapy, the investigators aim to strategize appropriate neoadjuvant chemotherapy before surgery, thus developing a platform to predict the outcomes of each patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with resectable pancreatic cancer after neoadjuvant chemotherapy | Not described Receives: Other: Organoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
The percentage of people in a group who are still alive for a certain period of time after they were started adjuvant chemotherapy for pancreatic cancer
Measured: From date of initiation of adjuvant chemotherapy after surgery until the date of death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion7 Jan 2025 (estimated)
- Study completion7 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JooKyung Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777604
- Sponsor's protocol ID
- 2020-12-106
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Prediction Platform for Neoadjuvant Treatment and Prognosis in Pancreatic Cancer Using Ex Vivo Analysis of Organoid Culture
- ClinicalTrials.gov ID
- NCT04777604
- Acronym / sponsor ID
- 2020-12-106
- Conditions
- Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 7 Jan 2025 (estimated)
- Study completion
- 7 Jan 2026 (estimated)
- First posted
- 2 Mar 2021 (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.
The investigators create organoid from the pancreatic cancer tissue obtained via EUS-FNA and EUS-FNB within the pancreatic cancer diagnostic process. And also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. Check for the reactivity to anti-cancer drugs through cell viability assay after treating with various anti-cancer drugs, such as anti-cancer drugs used as neoadjuvant chemotherapy for pancreatic cancer to the organoid. Also, perform genomic analysis on each organoid, and then check if there are any unique genomic mutations for each organoid. By recognizing the relationship between the unique genomic mutations and reactivity to the anti-cancer drug within pancreatic cancer patients eligible for surgery, the investigators aim to strategize appropriate neoadjuvant chemotherapy before surgery, thus developing a platform to predict the outcomes of each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with resectable pancreatic cancer after neoadjuvant chemotherapy | – | Other: Organoid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A patient who is in need of neoadjuvant chemotherapy before surgery, having been diagnosed with pancreatic cancer via EUS-FNA and EUS-FNB at Samsung Medical Center. And a patient who is eligible for surgery after neoadjuvantchemotherapy.
Key inclusion criteria (8 listed)
- 18 years old or older
- Newly discovered pancreatic cancer and not a relapse
- Diagnosed with pancreatic cancer via EUS-FNA, EUS-FNB before surgery
- who is in need of neoadjuvant chemotherapy before surgery
- Patients who can undergo surgery for pancreatic cancer after neoadjuvant chemotherapy
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| OrganoidThe investigators create organoid from the pancreatic cancer tissue obtained via EUS-FNA and EUS-FNB within the pancreatic cancer diagnostic process. And also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. Check for the reactivity to anti-cancer drugs through cell viability assay after treating with various anti-cancer drugs, such as anti-cancer drugs used as neoadjuvant chemotherapy for pancreatic cancer to the organoid. Also, perform genomic analysis on each organoid, and then check if there are any unique genomic mutations for each organoid. By recognizing the relationship between the unique genomic mutations and reactivity to the anti-cancer drug within patients with resectable pancreatic cancer after neoadjuvant chemotherapy, the investigators aim to strategize appropriate neoadjuvant chemotherapy before surgery, thus developing a platform to predict the outcomes of each patient. | Other | Patients with resectable pancreatic cancer after neoadjuvant chemotherapy |
Primary outcome
Overall survival rate
Time frame: From date of initiation of adjuvant chemotherapy after surgery until the date of death from any cause, assessed up to 36 months
The percentage of people in a group who are still alive for a certain period of time after they were started adjuvant chemotherapy for pancreatic cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreas Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 8 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 2 Mar 2021. 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 South Korea. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: From date of initiation of adjuvant chemotherapy after surgery until the date of death from any cause, assessed up to 36 months). 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 2 Mar 2021.