- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04996355
Organoids-on-a-chip for Colorectal Cancer and in Vitro Screening of Chemotherapeutic Drugs
August 12, 2021 updated by: Peking University People's Hospital
Prospective Observation on the Accuracy of in Vitro Screening of Colorectal Cancer Chemotherapy Drugs Based on Organoids-on-a-chip
The individualized treatment of tumors has always been an urgent problem in clinical practice.
Organoids-on-a-chip can reflect the heterogeneity of tumors and is a good model for in vitro anticancer drug screening.
In this study, surgical specimens of patients with advanced colorectal cancer will be collected for organoid culture and organoids-on-a- chip.
Use organoids-on-a-chip to screen tumor chemotherapy drugs, compare the results of patients' actual medication regimens, and study the guiding role of organoids in the formulation of precise tumor treatment plans.
The investigators will compare the response of organoids to drugs in vitro with the patient's response to actual chemotherapy and targeted drugs and explore the feasibility and accuracy of organoids-on-a-chip based drug screening for advanced colorectal cancer.
The project will establish a screening platform for chemotherapeutic drugs and targeted drugs based on colorectal cancer organoids to quickly and accurately formulate personalized treatment plans for clinical patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
- Establish and identify colorectal cancer organoid chip culture system: collect tumor tissues and normal tissues from patients with advanced colorectal cancer. Culture primary organoids, and organoids derived from normal mucosal tissues as controls. Validate tumor organoids and organoid chips by morphology (HE, immunohistochemical staining) and gene sequencing (target-seq) methods.
- After each enrolled patient undergoes MDT discussion, chemotherapy is given to the patient according to the existing clinical guidelines and clinical pathways for colorectal cancer. Meanwhile, in vitro drug screening based on colorectal cancer organoid chips is conducted. Collect target gene sequencing results and common clinical medication plans. Local recurrence rate, disease progression-free survival rate and overall survival rate will be followed up for 2 years.
- Compare the patient's response to the actual medication regimen and organoids in vitro drug screening based on organoids-on-a-chip, and evaluate the accuracy, specificity and sensitivity of organoids-on-a-chip for in vitro drug screening.
Study Type
Observational
Enrollment (Anticipated)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yancheng Cui, M.d.
- Phone Number: +8615201277974
- Email: cuiyancheng2007@163.com
Study Locations
-
-
-
Beijing, China, 100044
- Recruiting
- Peking University People's Hospital
-
Contact:
- Yancheng Cui, MD
- Phone Number: +8615201277974
- Email: cuiyancheng2007@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Each patient should complete the following items within two weeks of admission, which should be completed by the Gastrointestinal Surgery Department of Peking University People's Hospital:
- Complete medical history;
- Detailed personal data;
- Current treatment;
- Physical examination;
- Blood routine examination;
- Liver and kidney function examination;
- Tumor marker examination included CEA, CA199, CA724, AFP;
- Infection, blood coagulation examination;
- ECG, Ultrasound, Chest radiograph, Gastroenterostomy, and Imaging examination of tumor lesions.
Description
Inclusion Criteria:
- Patients voluntarily participate the study and sign informed consent, with good compliance and follow-up;
- Patients who can tolerate chemotherapy and targeted therapy, ECOG≤1 point;
- Patients with advanced colorectal cancer diagnosed by pathology and imaging; 4. Neutrophil count ≥2.0×10^9/L, Platelet count ≥100×10^9/L, Hemoglobin ≥90g/L, Serum total bilirubin ≤ 1.5 times the upper limit of normal value, Alanine aminotransferase and Aspartate aminotransferase ≤ 1.5 times the upper limit of normal value, and Serum creatinine ≤ 1.5 times the upper limit of normal value.
Exclusion Criteria:
- Patients who cannot obtain enough tissue for gene test and the organoids-on-a-chip culture;
- Patients previously combined with other malignant tumors of other organs;
- Patients who need emergency operation due to perforation and obstruction;
- Patients who have active hepatitis, HIV (+) and other conditions that cannot tolerate chemotherapy;
- Patients who have serious heart and lung diseases, vascular diseases, mental diseases or drug abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The accuracy, specificity and sensitivity of organoids-on-chip for drug sreening
Time Frame: 2 years
|
The accuracy, specificity and sensitivity of in vitro drug sensitivity screening based on organoid-chips to predict the effect of chemotherapy (traditional chemotherapy, targeted therapy) for advanced colorectal cancer.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yingjiang Ye, PHD&MD, Peking University People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 31, 2021
Primary Completion (ANTICIPATED)
May 30, 2022
Study Completion (ANTICIPATED)
May 30, 2024
Study Registration Dates
First Submitted
August 2, 2021
First Submitted That Met QC Criteria
August 2, 2021
First Posted (ACTUAL)
August 9, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 18, 2021
Last Update Submitted That Met QC Criteria
August 12, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021PHB148-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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