Individualized Precision Treatment Based on Ovarian Cancer Organoid Model

Not Applicable

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Device: Organoid culture

• Registration Number: NCT05813509
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief Summary

The research purpose of this study is to use organoid cultured from patients' own ovarian cancer tissues as models, screen potential clinical therapeutic drugs (such as paclitaxel, gemcitabine, etc.) in vitro, formulate individualized drug treatment plans for individual patient, and evaluate the clinical application value of organ like drug sensitivity technology.

Detailed Description

Under the guidance of ultrasound, the lesions were punctured to obtain tumor cells; The cells were amplified and cultured by organ like culture method to establish ovarian cancer like organoid. The drug sensitivity tests of different drugs were carried out on similar organs. Number of drugs tested: 10 (paclitaxel, carboplatin, lobaplatin, doxorubicin, etc.); After the test is completed, sufficient chemotherapy for full course of treatment shall be carried out according to the drug sensitivity results; After chemotherapy, blood and imaging evaluation were performed; Collect the information of patients from initial treatment to the end of chemotherapy; Matching the corresponding number of patients with platinum resistant relapse who did not undergo organ like culture; At each end point, the evaluation and comparison were carried out and the research conclusions were drawn.

Study Timeline

• Status Verified: 2022-12
• Study Start: 2022-12-01
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-14
• Last Update Posted: 2023-04-14
• Primary Completion: 2024-12-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Platinum resistant ovarian cancer	Organoid culture	Advanced-stage epithelial ovarian cancer (stage III or above) that has received more than 2 lines of chemotherapy and recurred within 6 months after the chemotherapy is stopped;

Primary Outcome Measures

Name	Time	Method
Objective remission rate	6 months	partial or complete remission ratio according to RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Progression free survival	3 years

Trial Locations

Locations (1)

First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China