SERS-Based Serum Molecular Spectral Detection of Invasive Lung Cancer

Official title

SERS-Based Serum Molecular Spectral Detection of Lung Cancer Microinvasion Versus Invasion Screening: A Multicenter, Open-Label, Double-Blind, Independent Data Analysis Clinical Trial

Overview

Surgery is the main treatment for early lung cancer. It is worth noting that there are significant differences in postoperative prognosis and surgical methods between microinvasive cancer and early-stage invasive cancer. Micro invasive lung cancer can achieve 100% long-term survival through surgical resection, without the need for postoperative adjuvant radiotherapy. There is no need to remove lung lobes during surgery, only segmental or wedge resection is required, and systematic lymph node dissection is not recommended. Therefore, accurate prediction of preoperative and intraoperative microinvasive cancer and invasive cancer in pulmonary nodules is crucial for patients to choose surgical methods, which can significantly affect postoperative lung function retention and overall survival. Raman spectroscopy (RS), as a non-invasive and highly specific molecular detection technique, can be obtained at the molecular level to sensitively detect changes in biomolecules composed of proteins, nucleic acids, lipids, and sugars related to tumor metabolism in biological samples. The surface enhanced Raman spectroscopy (SERS) developed based on this technology is one of the feasible methods for high-sensitivity biomolecule analysis. We collected serum Raman spectroscopy data from a cohort of 138 early lung cancer patients in our preliminary research. Based on a machine learning model, we constructed an early lung microinvasive cancer and invasive cancer Raman intelligent diagnosis system, which achieved an accuracy rate of 89.4%. To obtain the highest level of clinical evidence and truly achieve clinical translation, this prospective, multicenter clinical study aims to validate the use of this intelligent diagnostic system for early diagnosis of lung cancer and the discrimination between microinvasive cancer and invasive cancer.

Detailed description

1. Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures. 2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. 3. Completion of baseline procedures, participants were assessed for 30 days and completed all safety monitoring. 4. After completing the baseline assessment and confirming enrollment, participants will be given 2ml of fasting venous blood.

Interventions

• Diagnostic test Serum Raman spectroscopy intelligent diagnostic system
  Serum Raman spectroscopy intelligent diagnostic system Description: 1. Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures. 2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. 3. The following is the general sequence of events during the 3 months evaluation period: 4. Completion of baseline procedures Participants were assessed for 3 months and completed all safe

Primary outcome measures

• Diagnostic accuracy [Time frame: through study completion, an average of 1 year]
• Time to RAMAN diagnosis [Time frame: up to 30 days]

Secondary outcome measures (1)

• Safety assessment Results [Time frame: up to 30 days]

Eligibility criteria

Inclusion criteria

• Participants confirmed by chest CT to have pulmonary nodules
• The diagnosis of participants with malignant pulmonary nodules must meet the TNM diagnostic criteria (Ninth Edition);
• Participants are willing to participate in this study and follow the research plan;
• Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website;

Exclusion criteria

• Participants with concomitant other malignant tumors;
• Participants with missing baseline clinical data;
• Participants with severe underlying lung diseases (such as bronchiectasis, bronchial asthma or COPD, etc.), or those with a history of occupational or environmental exposure to dust, mines or asbestos;
• Participants who do not cooperate or refuse to participate in clinical trials at a later stage.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• The 900th Hospital of the Joint Logistic Support Force, PLA — Fuzhou

Identifiers

NCT: NCT06775015 · 2024-043

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗