None
Conditions
Interventions
Gold Standard:The pathological test results of tumor tissue biopsy samples (for validation of CTC markers), and the commercially available CTC detection systems (such as CellSearch®) (for validation o
Index test:"Integrated CTC Detection Platform" (comprising enrichment equipment, reagents, and a microscope scanning system), which is used to detect CTC counts and their HER2/PD-L1 molecular phenotyp
Sponsors
South China Hospital of Shenzhen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. Research participants meeting the corresponding cohort conditions (any one of the following conditions a or b can be included): a. Cohort 1: Healthy research participants without a history of cancer diagnosis/treatment or cancer-related symptoms within 30 days prior to enrollment. b. Cohorts 2, 3, 4: Patients diagnosed with advanced cancer (stage III - IV) by histopathology. Among them: - All patients were included in cohort 2 (baseline cohort). - Tumor patients who were HER2 positive and planned to start standard anti-HER2 targeted therapy were additionally included in cohort 3. - Tumor patients who were PD-L1 positive and planned to start standard immunotherapy were additionally included in cohort 4. ; 3. The clinical background information is complete, including at least gender, age, clinical diagnosis, etc. 4. Those who voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who have previously received similar targeted/immunotherapy as part of this study (i.e., those who are planned to receive anti-HER2 treatment, excluding those who have already received anti-HER2 treatment; those who are planned to receive PD-1/PD-L1 inhibitor treatment, excluding those who have already received similar immunotherapy); 2. Pregnant or lactating women; 3. Any conditions that the researchers consider unsuitable for inclusion and that may affect the scientific validity, safety, or rights of the subjects of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC value;sensitivity;specificity; | — |
Countries
China
Contacts
Public ContactWu Yang
South China Hospital of Shenzhen University
Outcome results
None listed