The Culture of Ovarian Cancer Organoids and Drug Screening

Last updated: August 29, 2023
Sponsor: Chongqing University Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cancer

Vaginal Cancer

Pelvic Cancer

Treatment

no intervention

Clinical Study ID

NCT04768270
CQGOG0201
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ovarian cancer patients who will accept primary cytoreductive surgery, withhistopathological type: low/high grade serous carcinoma, clear cell carcinoma,endometrioid carcinoma, mucinous carcinoma.
  2. ECOG score 01,age 1870 years old
  3. Expected survival over 6 months
  4. The serum or urine pregnancy test must be negative within 7 days before enrollment forthe women of childbearing age who should agree that contraception must be used duringthe 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

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 congenitalimmunodeficiency disease
  4. Chronic renal insufficiency or renal failure
  5. Has combined with other malignant tumor which diagnosed within 5 years and/or neededto be treated
  6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 forcongestive heart failure
  7. During the treatment for complications, the drugs which lead to serious liver and/orkidney function impairment need to be used, such as tuberculosis

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: no intervention
Phase:
Study Start date:
April 12, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Chongqing Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Active - Recruiting

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