Clinical trial NCT06100016: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Organoids
Lead sponsor: China Medical University, China
Sponsor class: OTHER
Collaborators: name: Institute of Health and Medical Technology, Hefei Institutes of Physical Science, Chinese Academy of Sciences
name: Precedo Pharmaceuticals Co. Ltd.
name: Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China
First posted: 2023-10-25
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with colorectal cancer in the First Affiliated Hospital of China Medical University

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival
timeFrame: From date of surgery until the date of first documented recurrence，up to 3 years
measure: Sensitivity
timeFrame: Through study completion, an average of 1 year
measure: Specificity
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Phase I Clinical Trials Center Of The First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: The First Affiliated Hospital of China Medical Univeristy
name: Zhenning Wang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of China Medical Univeristy
name: Funan Liu, doctor
role: PRINCIPAL_INVESTIGATOR
References: