Organoids-on-a-chip for Colorectal Cancer and in Vitro Screening of Chemotherapeutic Drugs

NCT04996355 | Unknown

• 1 other identifier: 2021PHB148-001
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Neoplasms; Organoids

Keywords

organoids; colorectal cancer; drug screening; organoids-on-a-chip

Outcome Measures

Primary Outcomes (1)

• The accuracy, specificity and sensitivity of organoids-on-chip for drug sreening

  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

Interventions

comprehensive treatment after MDT discussion OTHER

The comprehensive treatment plan was determined through MDT discussion, which was completed by the Department of Gastrointestinal Surgery, Peking University People's Hospital. The following regimens will be tested with organoids-on-a-chip： 1. 5-FU 2. Oxaliplatin 3. Irinotecan 4. 5-FU+ Oxaliplatin 5. 5-FU+ Irinotecan 6. 5-FU+ Oxaliplatin+ Irinotecan 7. 5-FU+Cetuximab 8. Cetuximab 9. Regorafenib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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: 1. Complete medical history； 2. Detailed personal data； 3. Current treatment； 4. Physical examination； 5. Blood routine examination； 6. Liver and kidney function examination； 7. Tumor marker examination included CEA, CA199, CA724, AFP； 8. Infection, blood coagulation examination； 9. ECG, Ultrasound, Chest radiograph, Gastroenterostomy, and Imaging examination of tumor lesions.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissue，blood sample,

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yingjiang Ye, PHD&MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yancheng Cui, M.d.

CONTACT

+8615201277974; cuiyancheng2007@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 9, 2021
• Study Start: May 31, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2024
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

CN (1)