Circulating Tumor CellNCT04688606
Circulating Tumor Cell Capture for Early Diagnosis and Postoperative Tumor Recurrence Monitoring of Liver Cancer
An observational study of Circulating Tumor Cell, run by Zhongnan Hospital at 1 site in China.
Trial summary
Through the screening of CTCs in patients with suspected liver cancer and liver tumor resection or liver transplantation, the number of CTCs in the blood of liver cancer patients before and after surgery is monitored, and the clinical application significance of CTCs in liver cancer screening and postoperative… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Circulating Tumor Cell
- What is being tested?
- Circulating tumor cell capture technology
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2020to 20 May 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Primary diagnosis of suspected hepatocellular carcinoma; or liver cancer patients who have undergone liver transplantation, radical resection or ablation of liver cancer; 2. Age 18-75 years old; 3. ASA (risk of anesthesia) score I-II; 4. The ECOG score is 0-1;
Who may be able to join
- Primary diagnosis of suspected hepatocellular carcinoma; or liver cancer patients who have undergone liver transplantation, radical resection or ablation of liver cancer;
- Age 18-75 years old;
- ASA (risk of anesthesia) score I-II;
- The ECOG score is 0-1;
Who cannot join
- In addition to hepatocellular carcinoma, patients diagnosed with other types of tumors;
- Patients with extrahepatic or lymphatic metastasis;
- Patients who still have serious complications 4 weeks after surgery;
- Patients who cannot provide informed consent;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Qifa Ye, +86-02767812988, 190679136@qq.com
Qifa Ye, MD
About this study
Official title: Zhongnan Hospital of Wuhan University
Through the screening of CTCs in patients with suspected liver cancer and liver tumor resection or liver transplantation, the number of CTCs in the blood of liver cancer patients before and after surgery is monitored, and the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in liver cancer patients is evaluated.
Read the detailed description
- Screen patients with suspected liver cancer Long-term exposure to liver cancer risk factors (hepatitis B carriers, past history of schistosomiasis, long-term diet of Aspergillus food, history of liver cirrhosis, etc.), patients with liver cancer are initially suspected.
- Monitor the number of CTCs in the blood of patients with liver cancer before and after surgery Imaging examinations show that liver space is occupied by patients with suspected liver cancer. Use CTCBIOPSY® technology to monitor patients' surgical operations (including interventional therapy, tumor resection, or liver cancer liver transplantation) at different times 1-3 days before, 1 month after surgery, and 6 months after surgery The number of CTCs in peripheral blood.
- To evaluate the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in patients with liver cancer Combined with clinicopathology, tumor marker examination and imaging examination, clinical follow-up and follow-up, analyze the clinical significance of CTCs detection in liver cancer patients, and focus on evaluating the relationship between circulating tumor cells in liver cancer screening and postoperative recurrence, and establish a new The liver cancer prediction model improves the prognosis of liver cancer patients.
- Conditions
- Circulating Tumor Cell
- Being tested
- Circulating tumor cell capture technology
- Keywords
- Circulating tumor cells, hepatocellular carcinoma
- Medical subject headings
- Neoplastic Cells, Circulating, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor cell capture technologyDiagnostic test
CTCBIOPSY® automatic testing platform
| Study group | Role | What they receive |
|---|---|---|
| Two groups | 1. Initial diagnosis of suspected hepatocellular carcinoma;
2. patients undergoing liver transplantation, radical resection or ablation of liver cancer Receives: Diagnostic Test: Circulating tumor cell capture technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical detection of circulating tumor cells
To evaluate the specificity of CTCs for liver cancer screening and the feasibility of early recurrence after interventional therapy, tumor resection or liver transplantation
Measured: 2020.01.20-2021.02.28
Secondary outcomes (1)
Circulating tumor cell function detection and verification
Analyze the correlation between circulating tumor cells and clinical prognosis after liver cancer surgery and further mechanism exploration
Measured: 2020.03.01-2021.05.20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start22 Jan 2020
- Primary completion20 May 2021 (estimated)
- Study completion20 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor CellStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qifa Ye, Study director, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688606
- Sponsor's protocol ID
- 2020108
- Status last verified
- Jan 2020
- First submitted
- 24 Dec 2020
- Last updated
- 30 Dec 2020
- 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 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zhongnan Hospital of Wuhan University
- ClinicalTrials.gov ID
- NCT04688606
- Acronym / sponsor ID
- 2020108
- Conditions
- Circulating Tumor Cell
- Keywords
- Circulating tumor cells, hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 20 May 2021 (estimated)
- Study completion
- 20 May 2021 (estimated)
- First posted
- 30 Dec 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.
Through the screening of CTCs in patients with suspected liver cancer and liver tumor resection or liver transplantation, the number of CTCs in the blood of liver cancer patients before and after surgery is monitored, and the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in liver cancer patients is evaluated.
Detailed description
- Screen patients with suspected liver cancer Long-term exposure to liver cancer risk factors (hepatitis B carriers, past history of schistosomiasis, long-term diet of Aspergillus food, history of liver cirrhosis, etc.), patients with liver cancer are initially suspected.
- Monitor the number of CTCs in the blood of patients with liver cancer before and after surgery Imaging examinations show that liver space is occupied by patients with suspected liver cancer. Use CTCBIOPSY® technology to monitor patients' surgical operations (including interventional therapy, tumor resection, or liver cancer liver transplantation) at different times 1-3 days before, 1 month after surgery, and 6 months after surgery The number of CTCs in peripheral blood.
- To evaluate the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in patients with liver cancer Combined with clinicopathology, tumor marker examination and imaging examination, clinical follow-up and follow-up, analyze the clinical significance of CTCs detection in liver cancer patients, and focus on evaluating the relationship between circulating tumor cells in liver cancer screening and postoperative recurrence, and establish a new The liver cancer prediction model improves the prognosis of liver cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two groups | – | Diagnostic Test: Circulating tumor cell capture technology1. Initial diagnosis of suspected hepatocellular carcinoma; 2. patients undergoing liver transplantation, radical resection or ablation of liver cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Primary diagnosis of suspected hepatocellular carcinoma; or liver cancer patients who have undergone liver transplantation, radical resection or ablation of liver cancer; 2. Age 18-75 years old; 3. ASA (risk of anesthesia) score I-II; 4. The ECOG score is 0-1;
Key inclusion criteria (4 listed)
- Primary diagnosis of suspected hepatocellular carcinoma; or liver cancer patients who have undergone liver transplantation, radical resection or ablation of liver cancer;
- Age 18-75 years old;
- ASA (risk of anesthesia) score I-II;
- The ECOG score is 0-1;
Key exclusion criteria (4 listed)
- In addition to hepatocellular carcinoma, patients diagnosed with other types of tumors;
- Patients with extrahepatic or lymphatic metastasis;
- Patients who still have serious complications 4 weeks after surgery;
- Patients who cannot provide informed consent;
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 cell capture technologyCTCBIOPSY® automatic testing platform | Diagnostic test | Two groups |
Primary outcome
Clinical detection of circulating tumor cells
Time frame: 2020.01.20-2021.02.28
To evaluate the specificity of CTCs for liver cancer screening and the feasibility of early recurrence after interventional therapy, tumor resection or liver transplantation
1 secondary outcome
Circulating tumor cell function detection and verification
Time frame: 2020.03.01-2021.05.20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
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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.
Qifa Ye study director
Wuhan University
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 Circulating Tumor Cell, run by Zhongnan 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 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 30 Dec 2020. 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 Qifa Ye (+86-02767812988, 190679136@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical detection of circulating tumor cells (time frame: 2020.01.20-2021.02.28). 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 30 Dec 2020.