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The Culture of Advanced or Recurrent Ovarian Cancer Organoids and Drug Screening

Sponsor
Chongqing University Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05290961
Collaborator
(none)
30
Enrollment
1
Location
33.8
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Most ovarian cancer will relapse after standard therapy. Patients with recurrent ovarian cancer are resistant to platinum. Due to the high heterogeneity between ovarian cancer, individual precise therapy is of great importance. The study will establish ovarian cancer organoids, whose original tissues from the patients with advanced or recurrent ovarian cancer, their tumors cannot be excised completely. The organoids will be identified at the histopathological level and gene level for evaluating the consistency with the original tumor tissue. The drug's sensitivity and specificity are detected through the organoids model. Compared with the clinical efficiency of the actual drug regimen, the efficacy of the organoid drug screening model can be assessed. The aim is to construct a precise drug screening platform for advanced and recurrent ovarian cancer patients and innovate drug research and development.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This trial is a single-arm and prospective observational study. The subjects are the advanced or recurrent ovarian cancer patients, who are planned to undergo surgery, but the neoplastic lesions can't be excised thoroughly. They voluntarily participate in the study and sign an informed consent form. General information will be collected, including name, age, address and contact information. Comprehensive physical examination will be performed. Ovarian cancer tumor markers and imaging examinations (gastroenterostomy, ultrasound / CT / MRI or PET / CT) should be taken within 4 weeks before treatment. Histopathological and genetic characteristics were analyzed in organoids and paired primary tumors to confirm whether organoids faithfully recapitulated the original tumor tissues. The sensitivity and specificity of first-line and second-line drugs from NCCN guidelines will be detected on the organoids. Ovarian cancer (CA125、HE4、CEA、CA-199) markers will be tested within one week. After the treatment period of 3 and 6 months, the short-term efficacy will be evaluated according to the efficacy evaluation standard of solid tumor (Recist1.1) (the window period is 4 weeks). Biochemical indexes, adverse reactions, and prognosis (PFS, OS) will be followed. Compared with the efficacy of the actual clinical regimen, the potency of organoid as a drug screening model will be assessed.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Drug Response in Patient-derived Organoids Models of Advanced or Recurrent Ovarian Cancer, an Exploratory Research
    Actual Study Start Date :
    Mar 9, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival [2 years]

      Progression-free survival means the duration from enrollment to disease progression or death.

    Secondary Outcome Measures

    1. Overall survival [2 years]

      Overall survival means the duration from enrollment to death due to any cause. The last follow-up time is calculated as the death time for subjects who lost follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients voluntarily participated in the study and signed informed consent;

    2. The tumour cannot be excised thoroughly by surgery;

    3. ECOG score ≤ 2;

    4. Expected survival >6 months;

    5. Blood routine test: Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L;

    6. Both serum ALT and serum AST ≤ 2 × ULN； blood creatinine ≤ 1.5 × ULN;

    7. Unpregnant women (negative HCG) received contraception in the study;

    8. Good compliance is judged by researchers.

    Exclusion Criteria:

    1. Active or the uncontrol serious infections;

    2. Patients with liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral treatment;

    3. A history of immune deficiency, including HIV positive or other acquired congenital immune deficiency diseases;

    4. Chronic renal insufficiency and renal failure;

    5. Myocardial infarction, severe arrhythmia and congestive heart failure (≥ grade 2 according to NYHA classification);

    6. Autoimmune diseases, including systemic lupus erythematosus;

    7. Patients take drugs that damage liver and kidney function for other complications, such as tuberculosis;

    8. Patients cannot understand the experimental contents and refuse to sign the informed consent form;

    9. Other concomitant serious diseases harm the health of patients or interfere with the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chongqing University Cancer Hospital Chongqing Chongqing China 400000

    Sponsors and Collaborators

    • Chongqing University Cancer Hospital

    Investigators

    • Principal Investigator: Dongling Zou, M.D., Chongqing University Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dongling Zou, Director of Gynecologic Oncology Department, Chongqing University Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05290961
    Other Study ID Numbers:
    • CQGOG0202
    First Posted:
    Mar 22, 2022
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Mar 1, 2022
    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
    Keywords provided by Dongling Zou, Director of Gynecologic Oncology Department, Chongqing University Cancer Hospital
    Ovarian Neoplasms
    Organoids
    Drug Screening
    Additional relevant MeSH terms:
    Ovarian Neoplasms

    Study Results

    No Results Posted as of Mar 22, 2022