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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06100016
• Other study ID #: ZKPRS-CMU1H-02
• Status: Recruiting
• Start date: October 18, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: China Medical University, China
• Contact: Shuhui Song, bachelor
• Phone: 02483281137
• Email: 593900927[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 1, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Disease Susceptibility
• Organoids

Locations

Country	Name	City	State
China	Phase I Clinical Trials Center Of The First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (4)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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