Development of a Prediction Platform for Neoadjuvant Treatment and Prognosis in Pancreatic Cancer Using Organoid

Pancreas Cancer Clinical Trial

Official title:

Development of a Prediction Platform for Neoadjuvant Treatment and Prognosis in Pancreatic Cancer Using Ex Vivo Analysis of Organoid Culture

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04777604
• Other study ID #: 2020-12-106
• Status: Not yet recruiting
• Start date: March 1, 2021
• Est. completion date: January 7, 2026

Study information

• Verified date: February 2021
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 7, 2026
• Est. primary completion date: January 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years old or older

2. Newly discovered pancreatic cancer and not a relapse

3. Diagnosed with pancreatic cancer via EUS-FNA, EUS-FNB before surgery

4. who is in need of neoadjuvant chemotherapy before surgery

5. Patients who can undergo surgery for pancreatic cancer after neoadjuvant chemotherapy

6. Diagnosed with pancreatic cancer from the final tissue pathology diagnosis after surgery

7. Able to make decisions for oneself for participation

8. Has obtained voluntary consent in written form (if 70 years of age or older, receive consent from the guardian as well)

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Organoid
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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From date of initiation of adjuvant chemotherapy after surgery until the date of death from any cause, assessed up to 36 months