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

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05885815

Collaborator

(none)

500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Application of Surface-enhanced Raman Scatting (SERS) Technology in Clinical Diagnosis and Prognosis of Lung Cancer Immunotherapy

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Outcome Measures

Primary Outcome Measures

OS [From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months]
Time from randomization to death (from any cause).
PFS [From date of diagnosis until the date of first documented progression from any cause, whichever came first, assessed up to 24 months]
The time between the initiation of randomization and the occurrence (any aspect) of tumor progression or death (from any cause).
ORR [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]
Refers to the proportion of subjects whose tumors shrink by a certain amount and remain for a certain period of time, including those with CR+PR.
DOR [The time from first diagnosis of CR or PR to diagnosis of PD was calculated at 24 months of study.]
Is the time from the first documented response (CR or PR) to the first documented disease progression or death, whichever occurs first.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.
Male or female aged 18-75 years or more when signing ICF.
Fiberoptic bronchoscopy or percutaneous lung biopsy was performed.
Lung cancer cannot be surgically resected.
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:

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