Colorectal Cancer MetastaticNCT04525807
Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
An observational study of Colorectal Cancer Metastatic, run by Fudan University.
Trial summary
In order to more accurately discover the cause of drug resistance in tumor treatment, and to provide a new basis for precise treatment. Therefore, based on the umbrella theory of precision medicine, we carried out this single-center, prospective, and observational study to include patients with liver metastases from… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Multi-omics
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2022
- 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: Patients who were newly diagnosed with liver metastases from colorectal cancer (pathologically diagnosed as adenocarcinoma)
Who may be able to join
- ECOG score 0-2 points
- Pathologically diagnosed patients with colorectal cancer
- Combined with liver metastases confirmed by imaging, and the lesion is measurable (RECIST standard)
- The lesion is available
- First-line treatment failed; hematology, liver and kidney function tests are suitable for back-line treatment
- Informed consent
Who cannot join
- With brain metastases
- History of other malignancies
- Pregnancy or breastfeeding
- Have received other drug clinical studies within 30 days before the start of this study
About this study
In order to more accurately discover the cause of drug resistance in tumor treatment, and to provide a new basis for precise treatment.
Therefore, based on the umbrella theory of precision medicine, we carried out this single-center, prospective, and observational study to include patients with liver metastases from colorectal cancer. By combining genome, transcriptome, and proteomic sequencing data, we established a basis for colorectal cancer liver Transfer the multi-omics data of the sample, describe the reason for the resistance of the first-line treatment, and search for new therapeutic targets.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Multi-omics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-omicsDiagnostic test
Use multi-omics to analyze
| Study group | Role | What they receive |
|---|---|---|
| Multiomics arm | Guide therapy based on multi-omics Receives: Diagnostic Test: Multi-omics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete remission (CR) and partial remission (PR) cases
Measured: 1 year
Secondary outcomes (2)
progression-free survival
Refers to the date from initial diagnosis to tumor progression
Measured: 1 year
Overall survival
Refers to the date from initial diagnosis to last follow-up or death date
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 posted25 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525807
- Sponsor's protocol ID
- 2020-08
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
- ClinicalTrials.gov ID
- NCT04525807
- Acronym / sponsor ID
- 2020-08
- Conditions
- Colorectal Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 25 Aug 2020 (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.
In order to more accurately discover the cause of drug resistance in tumor treatment, and to provide a new basis for precise treatment.
Therefore, based on the umbrella theory of precision medicine, we carried out this single-center, prospective, and observational study to include patients with liver metastases from colorectal cancer. By combining genome, transcriptome, and proteomic sequencing data, we established a basis for colorectal cancer liver Transfer the multi-omics data of the sample, describe the reason for the resistance of the first-line treatment, and search for new therapeutic targets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiomics arm | – | Diagnostic Test: Multi-omicsGuide therapy based on multi-omics |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were newly diagnosed with liver metastases from colorectal cancer (pathologically diagnosed as adenocarcinoma)
Key inclusion criteria (6 listed)
- ECOG score 0-2 points
- Pathologically diagnosed patients with colorectal cancer
- Combined with liver metastases confirmed by imaging, and the lesion is measurable (RECIST standard)
- The lesion is available
- First-line treatment failed; hematology, liver and kidney function tests are suitable for back-line treatment
Key exclusion criteria (4 listed)
- With brain metastases
- History of other malignancies
- Pregnancy or breastfeeding
- Have received other drug clinical studies within 30 days before the start of this study
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 |
|---|---|---|
| Multi-omicsUse multi-omics to analyze | Diagnostic test | Multiomics arm |
Primary outcome
Objective response rate
Time frame: 1 year
Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete remission (CR) and partial remission (PR) cases
2 secondary outcomes
progression-free survival
Time frame: 1 year
Overall survival
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 25 Aug 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by Fudan University.
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 6 inclusion and 4 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 1 year). 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 25 Aug 2020.