Clinical trial NCT05885815: Application of SERS Technology in Clinical Diagnosis and Prognosis of Lung Cancer Immunotherapy
Official title: Application of Surface-enhanced Raman Scatting (SERS) Technology in Clinical Diagnosis and Prognosis of Lung Cancer Immunotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: SERS
probes
biopsy
immunotherapy
prognosis
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biopsy patients in Shanghai Pulmonary Hospital.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: OS
timeFrame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months
measure: PFS
timeFrame: From date of diagnosis until the date of first documented progression from any cause, whichever came first, assessed up to 24 months
measure: ORR
timeFrame: The proportion of patients who achieved a 30%(usual) reduction in tumor volume while maintaining the minimum required duration was calculated at month 24 of the study
measure: DOR
timeFrame: The time from first diagnosis of CR or PR to diagnosis of PD was calculated at 24 months of study.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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