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

July 12, 2023 updated by: Peking Union Medical College Hospital

Exploring the Application of 3D Bioprinting Technology in Constructing Preclinical Models of Pancreatic Cancer for Drug Sensitivity Testing and Its Significance in Personalized Treatment

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
      • Beijing, Beijing, China, 100029

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The patients with clinically and pathologically confirmed pancreatic ductal adenocarcinoma are considered potential candidates for this study. Clinical physicians will comprehensively document the medical history, including only patients above 18 years of age. Individuals with other malignant tumors or severe diseases will be excluded. Patients who are unable to provide independent informed consent will not be included in this study. All patients in this study will undergo adjuvant/neoadjuvant chemotherapy and surgical resection for the treatment of localized pancreatic ductal adenocarcinoma.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients
Time Frame: 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.
From enrollment to end within 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival time (PFS)
Time Frame: Up to 2 years.
The time from the start of postoperative adjuvant therapy to recurrence or death.
Up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDAC3DP001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.

IPD Sharing Time Frame

The IPD data will available after the study is completed.

IPD Sharing Access Criteria

Data can be accessed via e-mail with reasonable requests.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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