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2022-12-01
2024-06-30
2024-09-30
30
NCT05955092
Peking Union Medical College Hospital
Peking Union Medical College Hospital
OBSERVATIONAL
Exploring the Application of 3D Bioprinting for Personalized Treatment in Pancreatic Ductal Adenocarcinoma
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-07-04 | N/A | 2023-07-12 |
2023-07-12 | N/A | 2023-07-21 |
2023-07-21 | N/A | 2023-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients | 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. | From enrollment to end within 2 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-free survival time (PFS) | The time from the start of postoperative adjuvant therapy to recurrence or death. | Up to 2 years. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Yilei Mao Phone Number: 8600-010-69156042 Email: pumch-liver@hotmail.com |
Study Contact Backup Name: Hang Sun Phone Number: 8600-15626041366 Email: hangsunkcs@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
