Lung Cancer
Conditions
Interventions
Gold Standard:1. Chest CT and contrast-enhanced CT reveal lesions at the site, with no distant metastasis detected by PET-CT/MRI or other examinations. The clinical stage is I-III, and the condition i
Index test:The methylation levels of SHOX2 and PTGER4 in the patients serum.
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Healthy Subjects : 1. Age>=18 years old, male or female; 2. Have complete clinical data; 3. Have chest imaging examination images and reports that meet the requirements; 4. Chest imaging results are basically normal, no lung nodules; 5. Subjects or their legal guardians agree and sign the informed consent form, and they have the ability to comply with the study steps. Inclusion Criteria for Non-Healthy Subjects: 1. Age >=18 years old, male or female; 2. Lung cancer diagnosed by histopathology or cytopathology, or highly suspected lung cancer is judged by imaging and clinical data; 3. Complete PET-CT or other screenings (such as head enhanced magnetic resonance, whole body bone scan, chest enhanced CT, abdominal enhanced CT or ultrasound, neck lymph node ultrasound) no distant metastases were found, and the clinical stage was stage I-III, which could theoretically be cured by surgery; 4. No invasive biopsy for lung lesions or only surgical tissue biopsy or minimally invasive biopsy in internal medicine, and no other anti-tumor treatment; 5. Have complete clinical data; 6. Have chest imaging examination images and reports that meet the requirements; 7. Subjects or their legal guardians agree and sign the informed consent form, and they have the ability to comply with the study steps.
Exclusion criteria
Exclusion criteria: Exclusion criteria for healthy subjects Those with any of the following shall not be included in this study: 1. Chest imaging results indicate the presence of lung lesions, and its nature cannot be judged; 2. Female subjects of childbearing age who are pregnant, lactating, or have plans to conceive or breastfeed during the study period and do not take effective contraceptive measures; 3. History of malignant tumor disease; 4. Patients with co-infection or high fever within 4 weeks before screening, including but not limited to respiratory infection, nervous system infection, digestive system infection, urinary system infection, skin infection, etc.; 5. Combined with other acute or chronic diseases that affect the test results; 6. Patients who are not suitable to participate in clinical trials in the opinion of the investigator, including current physical or psychological conditions that make them unable to comply with the protocol. Exclusion criteria for non-healthy subjects Those with any of the following shall not be included in this study: 1. Preoperative clinical stage is stage IV lung cancer or inoperable stage III lung cancer; 2. Female subjects of childbearing age who are pregnant, lactating, or have plans to conceive or breastfeed during the study period and do not take effective contraceptive measures; 3. Have received or are receiving chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy and other anti-tumor treatments; 4. History of other systemic malignant tumors except lung cancer; 5. Patients with co-infection or high fever within 4 weeks prior to screening, including but not limited to respiratory infection, nervous system infection, digestive system infection, urinary system infection, skin infection, etc. 6. Concomitant with other serious diseases other than lung cancer, or an estimated survival time of = 8 weeks. Serious diseases are defined as: a certain disease that, according to the judgment of the investigator, may put the patient at risk, affect the results of the trial, or affect the patient's ability to participate in the trial, such as severe heart, lung, brain, liver, kidney, and hematological diseases; 7. Patients who are not suitable to participate in clinical trials according to the opinion of the investigator, including current physical or psychological conditions that make them unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of SHOX2 and PTGER4 methylation detection in blood samples for diagnosing early-to-mid-stage lung cancer;Methylation detection of SHOX2 and PTGER4 in blood samples for the diagnosis of early-to-mid-stage lung cancer specificity;Accuracy of SHOX2 and PTGER4 methylation detection in blood samples for diagnosing early-to-mid-stage lung cancer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive predictive value of blood sample methylation detection of SHOX2 and PTGER4 for diagnosing early-to-mid-stage lung cancer;Negative predictive value of blood sample methylation detection for SHOX2 and PTGER4 in diagnosing early-to-mid-stage lung cancer; | — |
Countries
China
Contacts
Public ContactYuying Li
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed