Circulating Tumor CellNCT05297955
Circulating Tumor Cell Detection in Hepatocellular Carcinoma
An observational study of Circulating Tumor Cell, run by Tongji Hospital at 1 site in China.
Trial summary
The investigators examined circulating tumor cells (CTC) in the perioperative peripheral blood of hundreds of HCC patients undergoing liver cancer surgery using CellSearch technology between 2013 and 2016. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Circulating Tumor Cell
- How many people
- 458 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2013to 15 Mar 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Perioperative patients with hepatocellular carcinoma who underwent CTC detection of peripheral blood
Who may be able to join
- The pathological diagnosis was primary liver cancer.
- Undergoing radical surgical treatment
- No preoperative antitumor therapy was received
- Between 18 and 80 years old
Who cannot join
- With distal metastasis
- With other tumors
- Perioperative death
- Recurrence within one month after surgery
- Lost contact before the first follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Retrospective Study of Data Related to Circulating Tumor Cell Detection in Hepatocellular Carcinoma
The investigators examined circulating tumor cells (CTC) in the perioperative peripheral blood of hundreds of HCC patients undergoing liver cancer surgery using CellSearch technology between 2013 and 2016. Although the investigators have done a preliminary study of the above data and published some results, the previous study was only a basic analysis. Now the investigators plan to carry out further in-depth analysis of these data, including hospitalization data, follow-up results, surgical tumors and blood specimens, and make full use of biostatistics, molecular biology, pathology and other related techniques to elucidate the association between the levels of CTC or CTC clusters and patients' disease during the perioperative period, and to explore the molecular basis of CTC production in hepatocellular carcinoma.
Read the detailed description
From 2013 to 2016, CellSearch technology was used to detect the number of circulating tumor cells (CTC) in peripheral blood of hundreds of HCC patients undergoing liver cancer surgery during perioperative period. The analysis results confirmed that the level of CTC before and after surgery were significantly correlated with overall survival (OS) and disease-free survival (DFS) of patients. CTC level changed before and after surgery, but there was no statistical difference. Preoperative CTC was more correlated with patients' disease-related clinical parameters, while postoperative CTC was an independent prognostic indicator of patients after surgery. In addition, the investigators' study found that CTC clusters level can be a new marker of tumor progression in HCC patients.
Based on the above data, the investigators will perform retrospective analysis to compare the relationship between CTC level and clinical indicators of HCC patients. Participants were divided into groups according to pathological type, differentiation degree, clinical stage, invasion degree, recurrence and metastasis of tumors. Combined with immunohistochemistry and quantitative PCR results, the correlation of CTC in tumor genesis, pathological model, degree of differentiation, tumor stage, invasion, metastasis and expression of other tumor markers was studied.
- Conditions
- Circulating Tumor Cell
- Medical subject headings
- Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The number of CTC in HCC patient great than or equal to two | According to the cutoff of CTC, the number of CTC in HCC patient great than or equal to two | |
| The number of CTC in HCC patient less than two | According to the cutoff of CTC,the number of CTC in HCC patient less than two |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data analysis of relationship between CTC and pathological indicators of hepatocellular carcinoma
The previous CTC detection data of 458 cases was collected. To compare the relationship between CTC level of perioperative peripheral blood and clinical indexes of HCC patients, the main statistical analysis were one-way ANOVA, Student's T test and Multivariable Cox regression.
Measured: 2022.03.15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Nov 2013
- Primary completion30 Jun 2016
- Study completion15 Mar 2022
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
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiaoping, Tongji Hospital
- Investigators
- Xiaoping Chen, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297955
- Sponsor's protocol ID
- TJ-IRB20211242
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 6 Apr 2022
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Data Related to Circulating Tumor Cell Detection in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05297955
- Acronym / sponsor ID
- TJ-IRB20211242
- Conditions
- Circulating Tumor Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 28 Mar 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.
The investigators examined circulating tumor cells (CTC) in the perioperative peripheral blood of hundreds of HCC patients undergoing liver cancer surgery using CellSearch technology between 2013 and 2016. Although the investigators have done a preliminary study of the above data and published some results, the previous study was only a basic analysis. Now the investigators plan to carry out further in-depth analysis of these data, including hospitalization data, follow-up results, surgical tumors and blood specimens, and make full use of biostatistics, molecular biology, pathology and other related techniques to elucidate the association between the levels of CTC or CTC clusters and patients' disease during the perioperative period, and to explore the molecular basis of CTC production in hepatocellular carcinoma.
Detailed description
From 2013 to 2016, CellSearch technology was used to detect the number of circulating tumor cells (CTC) in peripheral blood of hundreds of HCC patients undergoing liver cancer surgery during perioperative period. The analysis results confirmed that the level of CTC before and after surgery were significantly correlated with overall survival (OS) and disease-free survival (DFS) of patients. CTC level changed before and after surgery, but there was no statistical difference. Preoperative CTC was more correlated with patients' disease-related clinical parameters, while postoperative CTC was an independent prognostic indicator of patients after surgery. In addition, the investigators' study found that CTC clusters level can be a new marker of tumor progression in HCC patients.
Based on the above data, the investigators will perform retrospective analysis to compare the relationship between CTC level and clinical indicators of HCC patients. Participants were divided into groups according to pathological type, differentiation degree, clinical stage, invasion degree, recurrence and metastasis of tumors. Combined with immunohistochemistry and quantitative PCR results, the correlation of CTC in tumor genesis, pathological model, degree of differentiation, tumor stage, invasion, metastasis and expression of other tumor markers was studied.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The number of CTC in HCC patient great than or equal to two | – | –According to the cutoff of CTC, the number of CTC in HCC patient great than or equal to two |
| The number of CTC in HCC patient less than two | – | –According to the cutoff of CTC,the number of CTC in HCC patient less than two |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Perioperative patients with hepatocellular carcinoma who underwent CTC detection of peripheral blood
Key inclusion criteria (4 listed)
- The pathological diagnosis was primary liver cancer.
- Undergoing radical surgical treatment
- No preoperative antitumor therapy was received
- Between 18 and 80 years old
Key exclusion criteria (5 listed)
- With distal metastasis
- With other tumors
- Perioperative death
- Recurrence within one month after surgery
- Lost contact before the first follow-up
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
Data analysis of relationship between CTC and pathological indicators of hepatocellular carcinoma
Time frame: 2022.03.15
The previous CTC detection data of 458 cases was collected. To compare the relationship between CTC level of perioperative peripheral blood and clinical indexes of HCC patients, the main statistical analysis were one-way ANOVA, Student's T test and Multivariable Cox regression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- 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.
Xiaoping Chen study chair
Tongji Hospital
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 Tongji 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 5 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: finished, as of the sponsor's last update on 6 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Data analysis of relationship between CTC and pathological indicators of hepatocellular carcinoma (time frame: 2022.03.15). 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 6 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.