Exploring the Application of 3D Bioprinting for Personalized Treatment in Pancreatic Ductal Adenocarcinoma

Recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma

• Registration Number: NCT05955092
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The goal of this observational study is to test the application value of 3D bioprinting technology in personalized treatment of pancreatic cancer.

The main questions it aims to answer are:

* Can 3D bioprinting technology be successfully applied to establish preclinical models of pancreatic cancer?

* Can 3D bioprinted preclinical models of pancreatic cancer be applied to personalized treatment of pancreatic cancer?

Participants will have tumor tissue collected to extract primary tumor cells for the establishment of in vitro preclinical models, which will be used for drug sensitivity testing.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-12
• Last Update Submitted: 2023-07-12
• Study First Posted: 2023-07-21
• Last Update Posted: 2023-07-21
• Primary Completion: 2024-06-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• More than 18 years old
• Diagnosed as colorectal cancer with or without liver metastases before
• Pathologically proven colorectal cancer after surgery

Exclusion Criteria

• History of other malignancies or serious medical conditions
• Inability to provide independent informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients	From enrollment to end within 2 weeks	1. Evaluation of the efficacy of neoadjuvant therapy in clinical response using the internationally recognized Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Stable Disease (SD) and Partial Response (PR) are considered indicators of chemotherapy sensitivity (good response), while Progressive Disease (PD) is considered indicative of chemotherapy resistance (poor response).; 2. Drug sensitivity testing results were assessed using standardized IC50 values. The standardized IC50 values were treated as the testing variables, while the clinical response to chemotherapy was designated as the state variable. The ROC curves for both variables were analyzed, and the area under the curve (AUC) was calculated to assess their correlation. To analyze the correlation between the drug testing results and clinical prognosis, linear regression analysis was performed to evaluate the correlation between standardized IC50 values and patients' progression-free survival (PFS) values.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival time (PFS)	Up to 2 years.	The time from the start of postoperative adjuvant therapy to recurrence or death.

Trial Locations

Locations (2)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China