Back to resultsIndividualized Precision Treatment Based on Ovarian Cancer Organoid Model
Primary Purpose
Ovarian Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Organoid culture
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian cancer；Platinum-resistant；chemosensitivity
Eligibility Criteria
Inclusion criteria Patients diagnosed as primary nonmucous epithelial ovarian cancer with stage III or above by previous pathological diagnosis; According to the relevant standards formulated by the World Health Organization (WHO) in 2014, measurable or assessable lesions are determined; platinum-resistant epithelial ovarian cancer that has received more than 2 lines of chemotherapy; 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; The liver, kidney and bone marrow functions were good. Exclusion criteria Patients with other malignant tumors; Patients with nervous system diseases; Hepatitis B virus and human papilloma virus infection; Immune function defect or serious infection; Patients who cannot communicate effectively, disagree with the research requirements, and do not understand the research purpose.
Sites / Locations
- First Affiliated Hospital of Xiamen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Platinum resistant ovarian cancer
Arm Description
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;
Outcomes
Primary Outcome Measures
Objective remission rate
partial or complete remission ratio according to RECIST criteria
Secondary Outcome Measures
Progression free survival
Full Information
NCT ID
NCT05813509
First Posted
April 3, 2023
Last Updated
April 3, 2023
Sponsor
The First Affiliated Hospital of Xiamen University
1. Study Identification
Unique Protocol Identification Number
NCT05813509
Brief Title
Individualized Precision Treatment Based on Ovarian Cancer Organoid Model
Official Title
Chief Physician of Obstetrics and Gynecology Department of the First Affiliated Hospital of Xiamen University
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Xiamen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian cancer；Platinum-resistant；chemosensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platinum resistant ovarian cancer
Arm Type
Experimental
Arm Description
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;
Intervention Type
Device
Intervention Name(s)
Organoid culture
Intervention Description
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
Primary Outcome Measure Information:
Title
Objective remission rate
Description
partial or complete remission ratio according to RECIST criteria
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Patients diagnosed as primary nonmucous epithelial ovarian cancer with stage III or above by previous pathological diagnosis;
According to the relevant standards formulated by the World Health Organization (WHO) in 2014, measurable or assessable lesions are determined;
platinum-resistant epithelial ovarian cancer that has received more than 2 lines of chemotherapy;
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;
The liver, kidney and bone marrow functions were good.
Exclusion criteria
Patients with other malignant tumors;
Patients with nervous system diseases;
Hepatitis B virus and human papilloma virus infection;
Immune function defect or serious infection;
Patients who cannot communicate effectively, disagree with the research requirements, and do not understand the research purpose.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JianFa Lan, Doctor
Phone
18810535017
Email
407136123@qq.com
Facility Information:
Facility Name
First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengyi Chen, doctor
Phone
18810535290
Email
407136123@qq.com
12. IPD Sharing Statement
Learn more about this trial
Individualized Precision Treatment Based on Ovarian Cancer Organoid Model
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