Colorectal Cancer Stage IVNCT04917276
Treatment Response Prediction System of mCRC Patients Based on CTC
An observational study of Colorectal Cancer Stage IV and Circulating Tumor Cell, run by Fudan University.
Trial summary
This study enrolling patients with metastatic colorectal cancer. Detecting CTC at different points in the treatment process. Descripting the molecular atlas of CTC in mCRC patients. Building and validating a response prediction system of mCTC patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer Stage IV, Circulating Tumor Cell
- What is being tested?
- Circulating tumor cell
- How many people
- 100 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
- Adult, Older adult
Study population: Patients with metastatic colorectal cancer (with lung or liver metastases) who receiving chemotherapy with or without target therapy
Who may be able to join
- Age 18-80 years;
- histologically proven colorectal liver metastasis
- With liver-dominant disease (extrahepatic metastases limited to lung metastases)
- ECOG 0-1
- A life expectancy of ≥ 3 months
- Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3
- Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl
- Written informed consent for participation in the trial.
Who cannot join
- Other previous malignancy within 5 years
- Have metastases other than liver and lung metastases
- Receiving any treatment before first blood collection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Treatment Response Prediction System of Metastatic Colorectal Cancer Based on Circulating Tumor Cells
This study enrolling patients with metastatic colorectal cancer. Detecting CTC at different points in the treatment process. Descripting the molecular atlas of CTC in mCRC patients. Building and validating a response prediction system of mCTC patients.
- Conditions
- Colorectal Cancer Stage IV, 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 CTC in different time points of treatment (like PR, PD, pre and post-operation)
| Study group | Role | What they receive |
|---|---|---|
| Training Group | The training cohort that used to built the response prediction model Receives: Diagnostic Test: Circulating tumor cell | |
| Validation Group | The validation cohort that used to validate the response prediction 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 response prediction model
Measured: 1 year
Specificity
The specificity of the response prediction 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 posted8 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 Cancer Stage IVStudies 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
- 100 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
- NCT04917276
- Sponsor's protocol ID
- ZSCTC2
- Status last verified
- Apr 2021
- First submitted
- 2 Jun 2021
- Last updated
- 8 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 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Response Prediction System of Metastatic Colorectal Cancer Based on Circulating Tumor Cells
- ClinicalTrials.gov ID
- NCT04917276
- Acronym / sponsor ID
- ZSCTC2
- Conditions
- Colorectal Cancer Stage IV, Circulating Tumor Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 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
- 8 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.
This study enrolling patients with metastatic colorectal cancer. Detecting CTC at different points in the treatment process. Descripting the molecular atlas of CTC in mCRC patients. Building and validating a response prediction system of mCTC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | – | Diagnostic Test: Circulating tumor cellThe training cohort that used to built the response prediction model |
| Validation Group | – | Diagnostic Test: Circulating tumor cellThe validation cohort that used to validate the response prediction model |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic colorectal cancer (with lung or liver metastases) who receiving chemotherapy with or without target therapy
Key inclusion criteria (8 listed)
- Age 18-80 years;
- histologically proven colorectal liver metastasis
- With liver-dominant disease (extrahepatic metastases limited to lung metastases)
- ECOG 0-1
- A life expectancy of ≥ 3 months
Key exclusion criteria (3 listed)
- Other previous malignancy within 5 years
- Have metastases other than liver and lung metastases
- Receiving any treatment before first blood collection
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 CTC in different time points of treatment (like PR, PD, pre and post-operation) | Diagnostic test | Training Group, Validation Group |
Primary outcome
Sensitivity
Time frame: 1 year
The sensitivity of the response prediction model
Specificity
Time frame: 1 year
The specificity of the response prediction model
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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 Stage IV 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 8 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 8 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 8 Jun 2021.