The Culture of Ovarian Cancer Organoids and Drug Screening

Recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT04768270
• Lead Sponsor: Chongqing University Cancer Hospital

Brief Summary

The tumor organoids platform can provide the precise genetic information and phenotype, as well as the heterogeneity of the tumor, thus provide information on drug sensitivity specific to the patient.This is an exploratory research to see if organoids testing could help guide precision treatment for ovarian cancer(OC) patients.

Detailed Description

Tissue will be received from operative specimens( primary ovarian carcinoma) at time of primary cytoreductive surgery.Ovarian cancer(OC) organoids will be then cultured. Organoids will be validated with a combination of Next Generation Sequencing (NGS) analysis and immunohistochemistry (TP53, PAX8 etc). After then, the patient-derived organoids cultured from OC will be compared the sensitivity to standard regimens (chemotherapies and targeted agents) recommendated by NCCN guidlines versus patients treated in clinical practice.

Study Timeline

• Study First Submitted: 2021-02-20
• Study First Submitted QC: 2021-02-20
• Study First Posted: 2021-02-24
• Study Start: 2022-04-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

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

Inclusion Criteria

1. Ovarian cancer patients who will accept primary cytoreductive surgery, with histopathological type: low/high grade serous carcinoma, clear cell carcinoma, endometrioid carcinoma, mucinous carcinoma.
2. ECOG score 0~1,age 18~70 years old
3. Expected survival over 6 months
4. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
5. CBC：Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L；
6. Serum ALT≤2×UL, AST≤2×ULN；Serum creatinine≤1.5×ULN；

Exclusion Criteria

1. Activity or uncontrol severe infection
2. Liver cirrhosis, Decompensated liver disease
3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
4. Chronic renal insufficiency or renal failure
5. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
7. During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS	5 years	Progression-free survival
OS	5 years	Overall survival

Secondary Outcome Measures

Name	Time	Method
DCR	1 year	CR+PR+SD
ORR	1 year	CR+PR

Trial Locations

Locations (1)

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China