Colorectal NeoplasmsNCT04996355
Organoids-on-a-chip for Colorectal Cancer and in Vitro Screening of Chemotherapeutic Drugs
An observational study of Colorectal Neoplasms and Organoids, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms, Organoids
- What is being tested?
- comprehensive treatment after MDT discussion
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2021to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
Yancheng Cui, MD, +8615201277974, cuiyancheng2007@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Neoplasms, Organoids
- Being tested
- comprehensive treatment after MDT discussion
- Keywords
- organoids, colorectal cancer, drug screening, organoids-on-a-chip
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive treatment after MDT discussionOther
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：
- 5-FU
- Oxaliplatin
- Irinotecan
- 5-FU+ Oxaliplatin
- 5-FU+ Irinotecan
- 5-FU+ Oxaliplatin+ Irinotecan
- 5-FU+Cetuximab
- Cetuximab
- Regorafenib
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start31 May 2021
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
- Investigators
- Yingjiang Ye, PHD&MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996355
- Sponsor's protocol ID
- 2021PHB148-001
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observation on the Accuracy of in Vitro Screening of Colorectal Cancer Chemotherapy Drugs Based on Organoids-on-a-chip
- ClinicalTrials.gov ID
- NCT04996355
- Acronym / sponsor ID
- 2021PHB148-001
- Conditions
- Colorectal Neoplasms, Organoids
- Keywords
- organoids, colorectal cancer, drug screening, organoids-on-a-chip
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 31 May 2021 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive treatment after MDT discussionThe 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 | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingjiang Ye, PHD&MD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Organoids, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yancheng Cui, M.d. (+8615201277974, cuiyancheng2007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy, specificity and sensitivity of organoids-on-chip for drug sreening (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.