Application of SERS Technology in Clinical Diagnosis and Prognosis of Lung Cancer Immunotherapy

Shanghai Pulmonary Hospital, Shanghai, China

Status: Not yet enrolling

Conditions: Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05885815

2023HY0520

Details and patient eligibility

About

The aim of this study is to explore the application of surface-enhanced Raman scattering (SERS) technology and specific PD-L1 detection fluorescent probes in the clinical diagnosis and prognosis of lung cancer immunotherapy, and further promote the rapid diagnosis of lung cancer and the precision of tumor immunotherapy.

Full description

The aim of this study is to explore the application of surface-enhanced Raman scattering (SERS) system in the diagnosis of benign and malignant lung cancer biopsy, and to promote the rapid diagnosis of lung cancer. In addition, the correlation between tumor PH value, PD-L1 expression detected by fluorescent probes and the efficacy and prognosis of immunotherapy was explored. Based on this, the immunotherapy efficacy and prognosis prediction models based on patients' clinical information, PD-L1 expression by immunohistochemistry, PD-L1 expression by fluorescent probes and PH value detected by SERS were constructed to promote the precision of tumor immunotherapy.

Enrollment: 500 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Voluntary participation in clinical research; Fully understand and informed the study and sign the informed consent form (ICF); Be willing to follow and be able to complete all trial procedures.
2. Male or female aged 18-75 years or more when signing ICF.
3. Fiberoptic bronchoscopy or percutaneous lung biopsy was performed.
4. Lung cancer cannot be surgically resected.
5. At least one measurable target lesion assessed by IRRC according to RECIST 1.1. Patients must provide eligible tumor tissue for PD-L1 expression and PH measurement.

(7) Related laboratory tests suggested that chemotherapy and immunotherapy could be tolerated.

Exclusion criteria

1. NSCLC patients with unclear diagnosis;
2. Patients with contraindications to chemotherapy or immunotherapy.
3. Contraindication of lung biopsy.
4. Other active malignant tumors within the past year or at the same time.
5. The patient had a known history of psychotropic drug abuse or drug use; She had a history of alcohol abuse.
6. According to the investigator's judgment, the patient had other factors that may lead to early termination of the study.