Study on the Consistency Evaluation of Organoids Used in the Clinical Treatment of Ovarian Cancer With Anti-tumor Drugs

• Conditions: Organoid; Ovarian Cancer

• Registration Number: NCT05175326
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

This is a single-center, observational clinical study that plans to recruit 64 ovarian cancer patients within one year. The purpose of this study is to evaluate the consistency and accuracy of the organoid model derived from patients with ovarian cancer and the patient's clinical medication, so as to predict the clinical efficacy of anti-cancer drugs

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Study First Posted: 2022-01-03
• Last Update Posted: 2022-01-03
• Primary Completion: 2022-06-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients with ovarian cancer who are diagnosed as ovarian cancer by tissue and/or cytology and need neoadjuvant, adjuvant or standard treatment Age 18-75 years old (including 18 years old and 75 years old) It is clear that there are measurable lesions (according to RECIST1.1)

Exclusion Criteria

• Patients with concurrent radiotherapy and chemotherapy, less than half a year of radiotherapy, or patients undergoing radiotherapy during the study period During the study period, patients need other tumor treatment methods such as surgery, intervention, radiofrequency ablation, etc.

Immune deficiency or severe bone marrow suppression The patient has severe liver and kidney disease, cardiovascular disease, blood disease, etc.

Illegal use of drugs or chronic alcohol abuse or total daily alcohol intake> 50 g/d Lack of autonomy, unable to walk, or unable to participate in the 6-month follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prediction of the response to treatment by the patient-derived organoids	2021-2022	The drug sensitivity was tested on patient-derived tumour organoids, which is compared with clinical response of the chemo- or targeted therapy treatment.

Trial Locations

Locations (1)

The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China