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Trial Title:
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
NCT ID:
NCT06100016
Condition:
Colorectal Cancer
Organoids
Conditions: Official terms:
Colorectal Neoplasms
Disease Susceptibility
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
patients with colorectal cancer in the First Affiliated Hospital of China Medical
University
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Phase I Clinical Trials Center Of The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110001
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuhui Song, bachelor
Phone:
02483281137
Email:
593900927@qq.com
Start date:
October 18, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Funan Liu
Agency class:
Other
Collaborator:
Agency:
Institute of Health and Medical Technology, Hefei Institutes of Physical Science, Chinese Academy of Sciences
Agency class:
Other
Collaborator:
Agency:
Precedo Pharmaceuticals Co. Ltd.
Agency class:
Other
Collaborator:
Agency:
Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China
Agency class:
Other
Source:
China Medical University, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06100016
