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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04996355
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : August 18, 2021
Sponsor:
Collaborator:
Peking University
Information provided by (Responsible Party):
Peking University People's Hospital

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.

Condition or disease Intervention/treatment
Colorectal Neoplasms Organoids Other: comprehensive treatment after MDT discussion

Detailed Description:
  1. 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.
  2. 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.
  3. 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.

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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Observation on the Accuracy of in Vitro Screening of Colorectal Cancer Chemotherapy Drugs Based on Organoids-on-a-chip
Actual Study Start Date : May 31, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines


Intervention Details:
  • Other: comprehensive treatment after MDT discussion

    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


Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
tissue,blood sample,


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. Patients voluntarily participate the study and sign informed consent, with good compliance and follow-up;
  2. Patients who can tolerate chemotherapy and targeted therapy, ECOG≤1 point;
  3. 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:

  1. Patients who cannot obtain enough tissue for gene test and the organoids-on-a-chip culture;
  2. Patients previously combined with other malignant tumors of other organs;
  3. Patients who need emergency operation due to perforation and obstruction;
  4. Patients who have active hepatitis, HIV (+) and other conditions that cannot tolerate chemotherapy;
  5. Patients who have serious heart and lung diseases, vascular diseases, mental diseases or drug abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04996355


Contacts
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Contact: Yancheng Cui, M.d. +8615201277974 cuiyancheng2007@163.com

Locations
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China
Peking University People's Hospital Recruiting
Beijing, China, 100044
Contact: Yancheng Cui, MD    +8615201277974    cuiyancheng2007@163.com   
Sponsors and Collaborators
Peking University People's Hospital
Peking University
Investigators
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Principal Investigator: Yingjiang Ye, PHD&MD Peking University People's Hospital
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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04996355    
Other Study ID Numbers: 2021PHB148-001
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University People's Hospital:
organoids
colorectal cancer
drug screening
organoids-on-a-chip
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases