Individualized Precision Treatment Based on Ovarian Cancer Organoid Model

NCT ID: NCT05813509

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-02-01

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Platinum resistant ovarian cancer

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;

Group Type: EXPERIMENTAL

Organoid culture

Intervention Type: DEVICE

Tumor like organ is a kind of organ cultured from tissues of tumor patients, which is a small tumor growing in a culture dish. Compared with the traditional two-dimensional culture system, the most important feature of this technological innovation is that it can directly use the patient's own tissue to culture organ like cells. At the same time, these organ like cells can well replicate some key characteristics of the primary tumor and retain the pathological form and biological mechanism of the patient's tissue

Interventions

Organoid culture

Tumor like organ is a kind of organ cultured from tissues of tumor patients, which is a small tumor growing in a culture dish. Compared with the traditional two-dimensional culture system, the most important feature of this technological innovation is that it can directly use the patient's own tissue to culture organ like cells. At the same time, these organ like cells can well replicate some key characteristics of the primary tumor and retain the pathological form and biological mechanism of the patient's tissue

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed as primary nonmucous epithelial ovarian cancer with stage III or above by previous pathological diagnosis;

2. According to the relevant standards formulated by the World Health Organization (WHO) in 2014, measurable or assessable lesions are determined;

3. platinum-resistant epithelial ovarian cancer that has received more than 2 lines of chemotherapy;

4. There is no serious disease of important organs, and the patient can tolerate chemotherapy. Karnofsky score more than 60, and the expected survival period is more than half a year;

5. The liver, kidney and bone marrow functions were good.

Exclusion Criteria

1. Patients with other malignant tumors;

2. Patients with nervous system diseases;

3. Hepatitis B virus and human papilloma virus infection;

4. Immune function defect or serious infection;

5. Patients who cannot communicate effectively, disagree with the research requirements, and do not understand the research purpose.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

JianFa Lan, Doctor

Role: CONTACT

407136123@qq.com

18810535017

Facility Contacts

Zhengyi Chen, doctor

Role: primary

407136123@qq.com

18810535290

Other Identifiers

XMYY-2022KY110

Identifier Type: -

Identifier Source: org_study_id