To hear about similar clinical trials, please enter your email below
Trial Title:
Application of SERS Technology in Clinical Diagnosis and Prognosis of Lung Cancer Immunotherapy
NCT ID:
NCT05885815
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
SERS
probes
biopsy
immunotherapy
prognosis
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Biopsy patients in Shanghai Pulmonary Hospital.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
19 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
June 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Pulmonary Hospital, Shanghai, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05885815
