The Culture of Ovarian Cancer Organoids and Drug Screening

Ovarian Cancer Clinical Trial

Official title:

Drug Screening of Patient-derived Organoids From Ovarian Cancer Culture to Personalized Therapy,an Exploratory Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04768270
• Other study ID #: CQGOG0201
• Status: Recruiting
• Start date: April 12, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Chongqing University Cancer Hospital
• Contact: Dongling Zou, M.D.
• Phone: +8613657690699
• Email: cqzl_zdl[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• no intervention
It is an observation trial.

Locations

Country	Name	City	State
China	Chongqing Cancer Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing University Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free survival	5 years
Primary	OS	Overall survival	5 years
Secondary	ORR	CR+PR	1 year
Secondary	DCR	CR+PR+SD	1 year