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

NCT05290961 | Unknown

• 1 other identifier: CQGOG0202
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Neoplasms

Keywords

Ovarian Neoplasms; Organoids; Drug Screening

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

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

  2 years

Secondary Outcomes (1)

• Overall survival

  2 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients with advanced or recurrent ovarian cancer, who are planned to undergo surgery, but the tumour cannot be excised thoroughly. They voluntarily participate in the study and sign an informed consent form.

You may qualify if:

• Patients voluntarily participated in the study and signed informed consent;
• The tumour cannot be excised thoroughly by surgery;
• ECOG score ≤ 2;
• Expected survival \>6 months;
• Blood routine test: Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L;
• Both serum ALT and serum AST ≤ 2 × ULN； blood creatinine ≤ 1.5 × ULN;
• Unpregnant women (negative HCG) received contraception in the study;
• Good compliance is judged by researchers.

You may not qualify if:

• Active or the uncontrol serious infections;
• Patients with liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral treatment;
• A history of immune deficiency, including HIV positive or other acquired congenital immune deficiency diseases;
• Chronic renal insufficiency and renal failure;
• Myocardial infarction, severe arrhythmia and congestive heart failure (≥ grade 2 according to NYHA classification);
• Autoimmune diseases, including systemic lupus erythematosus;
• Patients take drugs that damage liver and kidney function for other complications, such as tuberculosis;
• Patients cannot understand the experimental contents and refuse to sign the informed consent form;
• Other concomitant serious diseases harm the health of patients or interfere with the study.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Related Publications (14)

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  PMID: 22459127 BACKGROUND

• Bergamaschi A, Hjortland GO, Triulzi T, Sorlie T, Johnsen H, Ree AH, Russnes HG, Tronnes S, Maelandsmo GM, Fodstad O, Borresen-Dale AL, Engebraaten O. Molecular profiling and characterization of luminal-like and basal-like in vivo breast cancer xenograft models. Mol Oncol. 2009 Dec;3(5-6):469-82. doi: 10.1016/j.molonc.2009.07.003. Epub 2009 Aug 4.

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  PMID: 19329995 BACKGROUND

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  PMID: 30228295 BACKGROUND

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  PMID: 29946163 BACKGROUND

• Sato T, Stange DE, Ferrante M, Vries RG, Van Es JH, Van den Brink S, Van Houdt WJ, Pronk A, Van Gorp J, Siersema PD, Clevers H. Long-term expansion of epithelial organoids from human colon, adenoma, adenocarcinoma, and Barrett's epithelium. Gastroenterology. 2011 Nov;141(5):1762-72. doi: 10.1053/j.gastro.2011.07.050. Epub 2011 Sep 2.

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• Gao D, Vela I, Sboner A, Iaquinta PJ, Karthaus WR, Gopalan A, Dowling C, Wanjala JN, Undvall EA, Arora VK, Wongvipat J, Kossai M, Ramazanoglu S, Barboza LP, Di W, Cao Z, Zhang QF, Sirota I, Ran L, MacDonald TY, Beltran H, Mosquera JM, Touijer KA, Scardino PT, Laudone VP, Curtis KR, Rathkopf DE, Morris MJ, Danila DC, Slovin SF, Solomon SB, Eastham JA, Chi P, Carver B, Rubin MA, Scher HI, Clevers H, Sawyers CL, Chen Y. Organoid cultures derived from patients with advanced prostate cancer. Cell. 2014 Sep 25;159(1):176-187. doi: 10.1016/j.cell.2014.08.016. Epub 2014 Sep 4.

  PMID: 25201530 BACKGROUND

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 immunohistochemistry, 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

13657690699; cqzl_zdl@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecologic Oncology Department

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: March 22, 2022
• Study Start: March 9, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)