The Culture of Advanced/Recurrent/Metastatic Colorectal Cancer Organoids and Drug Screening

NCT ID: NCT05304741

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

2020-01-01

Study Completion Date

2023-12-31

Brief Summary

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The study aims to establish an organoids platform and apply them to screen drugs for advanced/recurrent/metastatic colorectal cancer patients.

Detailed Description

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The study was designed as a prospective, observational clinical trial in a single center. We establish organoids derived from patients with advanced/recurrent/metastatic colorectal cancer. Organoids will be validated with a combination of Next Generation Sequencing (NGS) analysis and histopathology. Drug screening assay will be performed on organoids with the chemotherapy and targeted agents, and the sensitivity and speciality will be compared with the clinical practice.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Patients voluntarily participated in the study and signed informed consent;
2. ECOG score 0\~2;
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;
7. Colorectal cancer was unresectable and confirmed as adenocarcinoma by histopathology. Patients have no significant symptoms in the primary lesion (no bleeding, perforation and obstruction in the primary focus). Besides, the carcinoma is potentially resectable but the patient refuses surgery;
8. Patients can comply with the research scheme according to the judgment of the researcher.

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 a congenital immunodeficiency disease;
4. Chronic renal insufficiency or renal failure;
5. Other malignancies which diagnosed within 5 years or needed to be treated;
6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
7. Concomitant diseases are treated by drugs that impair liver or kidney function, such as tuberculosis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

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 University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dongling Zou

Role: CONTACT

13657690699

Facility Contacts

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Dongling Zou, M.D.

Role: primary

13657690699

References

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Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

Reference Type BACKGROUND
PMID: 30207593 (View on PubMed)

Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

Reference Type BACKGROUND
PMID: 26808342 (View on PubMed)

Feng RM, Zong YN, Cao SM, Xu RH. Current cancer situation in China: good or bad news from the 2018 Global Cancer Statistics? Cancer Commun (Lond). 2019 Apr 29;39(1):22. doi: 10.1186/s40880-019-0368-6.

Reference Type BACKGROUND
PMID: 31030667 (View on PubMed)

Xie YH, Chen YX, Fang JY. Comprehensive review of targeted therapy for colorectal cancer. Signal Transduct Target Ther. 2020 Mar 20;5(1):22. doi: 10.1038/s41392-020-0116-z.

Reference Type BACKGROUND
PMID: 32296018 (View on PubMed)

Kim M, Mun H, Sung CO, Cho EJ, Jeon HJ, Chun SM, Jung DJ, Shin TH, Jeong GS, Kim DK, Choi EK, Jeong SY, Taylor AM, Jain S, Meyerson M, Jang SJ. Patient-derived lung cancer organoids as in vitro cancer models for therapeutic screening. Nat Commun. 2019 Sep 5;10(1):3991. doi: 10.1038/s41467-019-11867-6.

Reference Type BACKGROUND
PMID: 31488816 (View on PubMed)

Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774.

Reference Type BACKGROUND
PMID: 29472484 (View on PubMed)

Narasimhan V, Wright JA, Churchill M, Wang T, Rosati R, Lannagan TRM, Vrbanac L, Richardson AB, Kobayashi H, Price T, Tye GXY, Marker J, Hewett PJ, Flood MP, Pereira S, Whitney GA, Michael M, Tie J, Mukherjee S, Grandori C, Heriot AG, Worthley DL, Ramsay RG, Woods SL. Medium-throughput Drug Screening of Patient-derived Organoids from Colorectal Peritoneal Metastases to Direct Personalized Therapy. Clin Cancer Res. 2020 Jul 15;26(14):3662-3670. doi: 10.1158/1078-0432.CCR-20-0073. Epub 2020 May 6.

Reference Type BACKGROUND
PMID: 32376656 (View on PubMed)

Other Identifiers

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CQGOG0501

Identifier Type: -

Identifier Source: org_study_id

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