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

Not yet recruiting

• Conditions: Pancreas Cancer
• Interventions: Other: Organoid

• Registration Number: NCT04777604
• Lead Sponsor: Samsung Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Last Update Submitted: 2021-02-26
• Study Start: 2021-03-01
• Study First Posted: 2021-03-02
• Last Update Posted: 2021-03-02
• Primary Completion: 2025-01-07
• Study Completion: 2026-01-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with resectable pancreatic cancer after neoadjuvant chemotherapy	Organoid	-

Primary Outcome Measures

Name	Time	Method
Overall survival rate	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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of