The Culture of Ovarian Cancer Organoids and Drug Screening

NCT ID: NCT04768270

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-12

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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no intervention

It is an observation trial.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Ovarian cancer patients who will accept primary cytoreductive surgery, with histopathological type: low/high grade serous carcinoma, clear cell carcinoma, endometrioid carcinoma, mucinous carcinoma.
2. ECOG score 0\~1,age 18\~70 years old
3. Expected survival over 6 months
4. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the 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 Criteria

1. Activity or uncontrol severe infection
2. Liver cirrhosis, Decompensated liver disease
3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
4. Chronic renal insufficiency or renal failure
5. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
7. During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chongqing University Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dongling Zou

Director of Gynecologic Oncology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dongling Zou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital

Locations

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Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dongling Zou, M.D.

Role: CONTACT

+8613657690699

Facility Contacts

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Dongling Zou, M.D.

Role: primary

+8613657690699

Other Identifiers

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CQGOG0201

Identifier Type: -

Identifier Source: org_study_id

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