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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Organoids

• Study Type: Observational
• Enrollment (Estimated): 105

Contacts and Locations

• Study Contact: Name: Shuhui Song, bachelor; Phone Number: 024 02483281137; Email: 593900927@qq.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Recruiting
      • Phase I Clinical Trials Center Of The First Hospital of China Medical University
      • Contact: Shuhui Song, bachelor; Phone Number: 02483281137; Email: 593900927@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with colorectal cancer in the First Affiliated Hospital of China Medical University

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	An Indicator of efficacy of postoperative adjuvant therapy	From date of surgery until the date of first documented recurrence，up to 3 years
Sensitivity	Cases in which drug susceptibility results are sensitive to the antineoplastic regimen as apercentage of the cases that are effective in clinical evaluation	Through study completion, an average of 1 year
Specificity	Cases in which drug susceptibility results are resistance to the antineoplastic regimen as apercentage of the cases that are ineffective in clinical evaluation	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Funan Liu
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 7, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Disease Susceptibility
• Other Study ID Numbers: ZKPRS-CMU1H-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No