Explore the Consistency of Drug Sensitivity Between Primary Colorectal Cancer and Liver MetastasesNCT05183425
Patient-derived Organoids Predicts the Clinical Efficiency of Colorectal Liver Metastasis
An observational study of Explore the Consistency of Drug Sensitivity Between Primary Colorectal Cancer and Liver Metastases, run by Changhai Hospital at 1 site in China.
Trial summary
Accumulating evidence indicates that patient- derived organoids (PDOs) can predict drug responses in the clinic. Metastasis is the main cause of death in colorectal cancer patients, and the treatment of patients with liver metastasis remains poor. Tumor heterogeneity is the cause of treatment failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Explore the Consistency of Drug Sensitivity Between Primary Colorectal Cancer and Liver Metastases
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with histologically proven colorectal cancer with liver metastasis.
Who may be able to join
- Histologically proven colorectal cancer with liver metastasis
- Aged between 18 and 70 years
- Written informed and signed consent
- Accessible to surgery sample of metastasis and primary tumor
Who cannot join
- Less than 18 years and older than 70 years
- Not able to give informed consent
- Not accessible to surgery sample
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Wei Zhang, 021-31161613, weizhang2000cn@163.com
About this study
Official title: The Exploratory Study of Patient-derived Organoids for the Prediction and Evaluation of Clinical Efficiency Effect of Colorectal Cancer Liver Metastasis
Accumulating evidence indicates that patient- derived organoids (PDOs) can predict drug responses in the clinic. Metastasis is the main cause of death in colorectal cancer patients, and the treatment of patients with liver metastasis remains poor. Tumor heterogeneity is the cause of treatment failure. In this study, we aim the investigate the consistency of drug sensitivity for the matched primary and metastatic tumor in patients with liver metastasis.
What is being measured
The primary outcome is the main question the study is designed to answer.
The consistency of drug sensitivity
To test the consistency of drug sensitivity of primary tumor and its matched liver metastasis
Measured: 3 years
Secondary outcomes (1)
The establishment of PDO
To test the rate of PDO derived from primary and matched metastatic colorectal cancer .
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Explore the Consistency of Drug Sensitivity Between Primary Colorectal Cancer and Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183425
- Sponsor's protocol ID
- CHCS-PDO
- Status last verified
- Jan 2022
- First submitted
- 26 Dec 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploratory Study of Patient-derived Organoids for the Prediction and Evaluation of Clinical Efficiency Effect of Colorectal Cancer Liver Metastasis
- ClinicalTrials.gov ID
- NCT05183425
- Acronym / sponsor ID
- CHCS-PDO
- Conditions
- Explore the Consistency of Drug Sensitivity Between Primary Colorectal Cancer and Liver Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jan 2022 (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.
Accumulating evidence indicates that patient- derived organoids (PDOs) can predict drug responses in the clinic. Metastasis is the main cause of death in colorectal cancer patients, and the treatment of patients with liver metastasis remains poor. Tumor heterogeneity is the cause of treatment failure. In this study, we aim the investigate the consistency of drug sensitivity for the matched primary and metastatic tumor in patients with liver metastasis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with histologically proven colorectal cancer with liver metastasis.
Key inclusion criteria (4 listed)
- Histologically proven colorectal cancer with liver metastasis
- Aged between 18 and 70 years
- Written informed and signed consent
- Accessible to surgery sample of metastasis and primary tumor
Key exclusion criteria (3 listed)
- Less than 18 years and older than 70 years
- Not able to give informed consent
- Not accessible to surgery sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The consistency of drug sensitivity
Time frame: 3 years
To test the consistency of drug sensitivity of primary tumor and its matched liver metastasis
1 secondary outcome
The establishment of PDO
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
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.
Department of Colorectal Surgery in Changhai Hospital
Shanghai, China
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 Explore the Consistency of Drug Sensitivity Between Primary Colorectal Cancer and Liver Metastases, run by Changhai 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 4 inclusion and 3 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 4 Feb 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The consistency of drug sensitivity (time frame: 3 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 4 Feb 2022.