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

Sponsor
Chongqing University Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05304741
Collaborator
(none)
30
Enrollment
1
Location
48
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Drug Screening of Patient-derived Organoids From Advanced/Recurrent/Metastatic Colorectal Cancer Culture to Personalized Therapy, an Exploratory Research
    Actual Study Start Date :
    Jan 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival [2 years]

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

    2. Overall Survival [3 years and 5 years]

      Overall survival means the duration from enrollment to death due to any cause. The last follow-up time is calculated as the death time for subjects who lost follow-up

    Secondary Outcome Measures

    1. Diagnostic Indicators [2 years]

      The sensitivity and specificity of organoids derived from colorectal cancer of predicting chemotherapy response of patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chongqing University Cancer Hospital Chongqing Chongqing China 400000

    Sponsors and Collaborators

    • Chongqing University Cancer Hospital

    Investigators

    • Principal Investigator: Dongling Zou, M.D., Chongqing University Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dongling Zou, Director of Gynecologic Oncology Department, Chongqing University Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05304741
    Other Study ID Numbers:
    • CQGOG0501
    First Posted:
    Mar 31, 2022
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dongling Zou, Director of Gynecologic Oncology Department, Chongqing University Cancer Hospital
    Drug Screening
    Advanced / Recurrent / Metastatic Colorectal Cancer
    Orgnoids
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Mar 31, 2022