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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05175326
Collaborator
(none)
64
Enrollment
1
Location
12
Anticipated Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    64 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study on the Consistency Evaluation of Organoids Used in the Clinical Treatment of Ovarian Cancer With Anti-tumor Drugs
    Actual Study Start Date :
    Nov 1, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Guangzhou Guangdong China

    Sponsors and Collaborators

    • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Investigators

    • Study Director: Rao Qunxian, The Sun Yat-sen Memorial Hospital of Sun Yat-Sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT05175326
    Other Study ID Numbers:
    • SYSEC-KY-KS-2021-294
    First Posted:
    Jan 3, 2022
    Last Update Posted:
    Jan 3, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Jan 3, 2022