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

Sponsor

Samsung Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04777604

Collaborator

(none)

300

Enrollment

Location

58.3

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer	Other: Organoid

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Jan 7, 2025

Anticipated Study Completion Date :

Jan 7, 2026

Arms and Interventions

Arm	Intervention/Treatment
Patients with resectable pancreatic cancer after neoadjuvant chemotherapy	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.

Arm

Intervention/Treatment

Patients with resectable pancreatic cancer after neoadjuvant chemotherapy

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

JooKyung Park, Associate Professor, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT04777604

Other Study ID Numbers:

2020-12-106

First Posted:

Mar 2, 2021

Last Update Posted:

Mar 2, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Mar 2, 2021