Colorectal CancerNCT04912882
Prognosis Predicting of CRC Patients Based on Morphology and Molecular Biomaker of CTC
An observational study of Colorectal Cancer and Circulating Tumor Cell, run by Fudan University.
Trial summary
Detecting circulating tumor cells from I-IV stage colorectal cancer patients pre-and post-operatively. Analyzing the morphology and biomarkers of CTCs and builting prognosis predicting model based on the morphology and biomarkers of CTCs. Verifying the prognosis model by the survival data. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Circulating Tumor Cell
- What is being tested?
- Circulating tumor cell
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2021to 1 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: I-IV stage colorectal cancer patients with resectable lesion(s) who not receive preoperative treatment
Who may be able to join
- Age 18-80 years;
- Histologically proven colorectal carcinoma (TNM stage I-IV)
- R0 resection is possible according to preoperative evaluation
- Written informed consent for participation in the trial.
Who cannot join
- Primary tumor or metastases not able to be removed radically
- Receiving any preoperative treatment (Including chemotherapy, radiotherapy and target therapy)
- Have other malignant tumors meanwhile
- Other previous malignancy within 5 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prognosis Predicting of CRC Patients Based on Morphology and Molecular Biomaker of Circulating Tumor Cells
Detecting circulating tumor cells from I-IV stage colorectal cancer patients pre-and post-operatively. Analyzing the morphology and biomarkers of CTCs and builting prognosis predicting model based on the morphology and biomarkers of CTCs. Verifying the prognosis model by the survival data.
- Conditions
- Colorectal Cancer, Circulating Tumor Cell
- Being tested
- Circulating tumor cell
- Medical subject headings
- Colorectal Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor cellDiagnostic test
detecting circulating tumor cell pre- and post operatively
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Training group including about 500 patients that be using to building the prognosis model Receives: Diagnostic Test: Circulating tumor cell | |
| Validation Group | Validation group including about another 500 patients that be using to validating the prognosis model Receives: Diagnostic Test: Circulating tumor cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The sensitivity of the predictive based on the number and type of circulating tumor cell
Measured: 1 year
Specificity
The specificity of predictive model based on the number and type of circulating tumor cell
Measured: 1 year
Secondary outcomes (1)
AUC
Area under curve of the predictive model
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start15 Jun 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 1,000 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
- NCT04912882
- Sponsor's protocol ID
- ZSCTC1
- Status last verified
- Apr 2021
- First submitted
- 2 Jun 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Predicting of CRC Patients Based on Morphology and Molecular Biomaker of Circulating Tumor Cells
- ClinicalTrials.gov ID
- NCT04912882
- Acronym / sponsor ID
- ZSCTC1
- Conditions
- Colorectal Cancer, Circulating Tumor Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 Jun 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.
Detecting circulating tumor cells from I-IV stage colorectal cancer patients pre-and post-operatively. Analyzing the morphology and biomarkers of CTCs and builting prognosis predicting model based on the morphology and biomarkers of CTCs. Verifying the prognosis model by the survival data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | – | Diagnostic Test: Circulating tumor cellTraining group including about 500 patients that be using to building the prognosis model |
| Validation Group | – | Diagnostic Test: Circulating tumor cellValidation group including about another 500 patients that be using to validating the prognosis model |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- I-IV stage colorectal cancer patients with resectable lesion(s) who not receive preoperative treatment
Key inclusion criteria (4 listed)
- Age 18-80 years;
- Histologically proven colorectal carcinoma (TNM stage I-IV)
- R0 resection is possible according to preoperative evaluation
- Written informed consent for participation in the trial.
Key exclusion criteria (4 listed)
- Primary tumor or metastases not able to be removed radically
- Receiving any preoperative treatment (Including chemotherapy, radiotherapy and target therapy)
- Have other malignant tumors meanwhile
- Other previous malignancy within 5 years
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 |
|---|---|---|
| Circulating tumor celldetecting circulating tumor cell pre- and post operatively | Diagnostic test | Training Group, Validation Group |
Primary outcome
Sensitivity
Time frame: 1 year
The sensitivity of the predictive based on the number and type of circulating tumor cell
Specificity
Time frame: 1 year
The specificity of predictive model based on the number and type of circulating tumor cell
1 secondary outcome
AUC
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Circulating Tumor Cell, 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 4 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 3 Jun 2021. 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?
Contact Jianmin Xu (+8613501984869, xujmin@aiiyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 1 year). The study lists 2 primary outcomes in all. 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 3 Jun 2021.