The Culture of Ovarian Cancer Organoids and Drug Screening

NCT04768270 | Unknown

• 1 other identifier: CQGOG0201
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

tumor organoids; drug sensitivity; precision treatment

Outcome Measures

Primary Outcomes (2)

• PFS

  Progression-free survival

  5 years

• OS

  Overall survival

  5 years

Secondary Outcomes (2)

• ORR

  1 year

• DCR

  1 year

Interventions

no intervention OTHER

It is an observation trial.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ovarian cancer patients who accept primary cytoreductive surgery

You may qualify if:

• Ovarian cancer patients who will accept primary cytoreductive surgery, with histopathological type: low/high grade serous carcinoma, clear cell carcinoma, endometrioid carcinoma, mucinous carcinoma.
• ECOG score 0\~1,age 18\~70 years old
• Expected survival over 6 months
• 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
• CBC：Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L；
• Serum ALT≤2×UL, AST≤2×ULN；Serum creatinine≤1.5×ULN；

You may not qualify if:

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

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Ovarian cancer tissues were cut into 1-3 mm3 pieces. Two random pieces were snap frozen and stored at -80℃ for DNA isolation, two random pieces were fixed in formalin for histopathological analysis, and the remainder was processed for organoids.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Dongling Zou, M.D.

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongling Zou, M.D.

CONTACT

+8613657690699; cqzl_zdl@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecologic Oncology Department

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 24, 2021
• Study Start: April 12, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

CN (1)