Viewing Study NCT05634694


Ignite Creation Date: 2025-12-25 @ 1:27 AM
Ignite Modification Date: 2025-12-27 @ 3:53 AM
Study NCT ID: NCT05634694
Status: UNKNOWN
Last Update Posted: 2022-12-02
First Post: 2022-11-16
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Study on Consistency Evaluation for Drug Sensitivity of Patient-Derived Organoid Model From Cholangiocarcinoma Patients
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:

Study Overview

Official Title: Clinical Study on the Drug Sensitivity Consistency of Patient-Derived Organoid Model and Actual Therapeutic Efficacies in Cholangiocarcinoma Patients Receiving Adjuvant Chemotherapy After Radical Resection
Status: UNKNOWN
Status Verified Date: 2022-11
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a single-center, prospective, observational and exploratory clinical study. The object of this study is to evaluate the consistency and accuracy of patient-derived organoid model of cholangiocarcinoma to predict the clinical chemotherapeutic efficacy, as well as the possibility of guiding the adjuvant chemotherapy.
Detailed Description: The chemotherapeutic efficacy is heterogeneous among cholangiocarcinoma patients after radical resection, and an accurate and relatively convenient model evaluating the chemotherapeutic efficacy is still lacking. This study aims to prospectively evaluate the consistency of drug sensitivity between patient-derived organoid model and the actual clinical chemotherapeutic efficacy in cholangiocarcinoma patients, assisting in guiding precision medicine and making therapeutic decisions.

Drug sensitivity tests include single drug and drug combination. The organoids that are successfully cultured will be kept in liquid nitrogen for a specific time.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: