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

Recruiting

• Conditions: Organoids; Colorectal Cancer

• Registration Number: NCT06100016
• Lead Sponsor: Funan Liu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-07
• Study Start: 2023-10-18
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Phase I Clinical Trials Center Of The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China