Clinical trial NCT04688606: Circulating Tumor Cell Capture for Early Diagnosis and Postoperative Tumor Recurrence Monitoring of Liver Cancer
Official title: Zhongnan Hospital of Wuhan University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Circulating Tumor Cell
Keywords: Circulating tumor cells, hepatocellular carcinoma
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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;

Brief 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 recurrence monitoring in liver cancer patients is evaluated.

Detailed description: 1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

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;

Exclusion Criteria:

1. In addition to hepatocellular carcinoma, patients diagnosed with other types of tumors;
2. Patients with extrahepatic or lymphatic metastasis;
3. Patients who still have serious complications 4 weeks after surgery;
4. Patients who cannot provide informed consent;

Primary outcomes:
measure: Clinical detection of circulating tumor cells
timeFrame: 2020.01.20-2021.02.28
Secondary outcomes:
measure: Circulating tumor cell function detection and verification
timeFrame: 2020.03.01-2021.05.20
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Qifa Ye
role: STUDY_DIRECTOR
References: