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NCT05175326 Clinical Trial

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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05175326
Other study ID # SYSEC-KY-KS-2021-294
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date November 1, 2022

Study information
Verified date December 2021
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Rao Qunxian
Phone 13902250700
Email raoqx3@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 64
Est. completion date November 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prediction of the response to treatment by the patient-derived organoids The drug sensitivity was tested on patient-derived tumour organoids, which is compared with clinical response of the chemo- or targeted therapy treatment. 2021-2022
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