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A Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Colorectal Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method

Sponsor
Funan Liu (Other)
Overall Status
Recruiting
CT.gov ID
NCT06100016
Collaborator
Institute of Health and Medical Technology, Hefei Institutes of Physical Science, Chinese Academy of Sciences (Other), Precedo Pharmaceuticals Co. Ltd. (Other), Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China (Other)
105
Enrollment
1
Location
25.5
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is a real-world observational clinical study. Patients diagnosed as colorectal cancer through histopathology were screened and enrolled. Before anti-tumor treatment, colonoscopy biopsy tissue specimens, surgical specimens, and malignant pleural effusion or ascites specimens, etc. are collected. The investigators will perform a drug sensitivity testing based on a novel drug susceptibility testing method to test the commonly used anti-tumor treatment regimens. Patients were given conventional anti-tumor treatment according to the medical judgment of the doctors. Finally, the investigator will evaluate the consistency of clinical efficacy in colorectal cancer treatment and drug susceptibility outcomes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    105 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Real-world Observational Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Colorectal Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method
    Anticipated Study Start Date :
    Oct 17, 2023
    Anticipated Primary Completion Date :
    Oct 31, 2025
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Disease-free survival [From date of surgery until the date of first documented recurrence，up to 3 years]

      An Indicator of efficacy of postoperative adjuvant therapy

    2. Sensitivity [Through study completion, an average of 1 year]

      Cases in which drug susceptibility results are sensitive to the antineoplastic regimen as apercentage of the cases that are effective in clinical evaluation

    3. Specificity [Through study completion, an average of 1 year]

      Cases in which drug susceptibility results are resistance to the antineoplastic regimen as apercentage of the cases that are ineffective in clinical evaluation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female, aged ≥ 18 and ≤80;

    2. Patients with colorectal cancer diagnosed by histopathology;

    3. Patients who need neoadjuvant treatment; adjuvant therapy after radical surgery or palliative treatment;

    4. Fresh tumor tissue specimens or malignant pleural effusion or ascites can be obtained;

    5. Patients who sign the informed consent form, and are able to comply with the study period treatment process.

    Exclusion Criteria:

    1. Inability to follow the research protocol;

    2. Inability to obtain relevant fresh specimens by biopsy/surgery/puncture;

    3. Concomitant contraindications to chemotherapy;

    4. pregnant or lactating women;

    5. Patients deemed inappropriate by investigators.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phase I Clinical Trials Center Of The First Hospital of China Medical University Shenyang Liaoning China 110001

    Sponsors and Collaborators

    • Funan Liu
    • Institute of Health and Medical Technology, Hefei Institutes of Physical Science, Chinese Academy of Sciences
    • Precedo Pharmaceuticals Co. Ltd.
    • Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China

    Investigators

    • Principal Investigator: Zhenning Wang, doctor, The First Affiliated Hospital of China Medical Univeristy
    • Principal Investigator: Funan Liu, doctor, The First Affiliated Hospital of China Medical Univeristy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Funan Liu, professor, China Medical University, China
    ClinicalTrials.gov Identifier:
    NCT06100016
    Other Study ID Numbers:
    • ZKPRS-CMU1H-02
    First Posted:
    Oct 25, 2023
    Last Update Posted:
    Oct 25, 2023
    Last Verified:
    Oct 1, 2023
    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
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Disease Susceptibility

    Study Results

    No Results Posted as of Oct 25, 2023