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Trial Title:
Individualized Precision Treatment Based on Ovarian Cancer Organoid Model
NCT ID:
NCT05813509
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
Ovarian cancer；Platinum-resistant；chemosensitivity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Organoid culture
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
Arm group label:
Platinum resistant ovarian cancer
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.
Criteria for 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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengyi Chen, doctor
Phone:
18810535290
Email:
407136123@qq.com
Start date:
December 1, 2022
Completion date:
February 1, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Source:
The First Affiliated Hospital of Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05813509
