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

NCT06100016 — Unknown, 105 participants, Funan Liu

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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

Registry	NCT06100016
Status	Unknown
Study type	Observational
Enrollment	105 (Estimated)
Sponsor	Funan Liu (Other); collaborators: Chinese Academy of Sciences, Precedo Pharmaceuticals Co. Ltd., Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China
Conditions	Colorectal Cancer, Organoids
Dates	start 2023-10-18, primary completion 2025-10-31 (estimated), completion 2025-12-01 (estimated), first posted 2023-10-25, last updated 2024-02-07
Locations	1 site in China

-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.

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+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.

+Locations (1)

Facility	City	Country	Status
Phase I Clinical Trials Center Of The First Hospital of China Medical University	Shenyang, Liaoning	China	Recruiting

+Investigators

Zhenning Wang, doctor, Principal investigator, The First Affiliated Hospital of China Medical Univeristy
Funan Liu, doctor, Principal investigator, The First Affiliated Hospital of China Medical Univeristy