Development and Application of Molecular Evaluation Instrument for Lung Cancer Diagnosis and Treatment

Study Overview
=================
Brief Summary
-----------------
The precise diagnosis and treatment of lung cancer is not only a major national strategic need but also an urgent demand from the general public. The three stages of precise diagnosis and treatment of lung cancer include early diagnosis, effective treatment, and precise evaluation. Currently, invasive methods are mainly used in these three stages of clinical practice. The non-invasive molecular diagnosis of early-stage lung cancer and the molecular evaluation of treatment efficacy are critical core issues in lung cancer clinical diagnosis and treatment. In response to this problem, this project aims to use exhaled breath as a sample to develop a scientific instrument with independent intellectual property rights, which integrates early-stage diagnosis of lung cancer and evaluation of treatment efficacy. We will also conduct related application research to meet the needs of the public and contribute to the health of the entire population.

Official Title
-----------------
Development and Application of Molecular Evaluation Instrument for Lung Cancer Diagnosis and Treatment

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntarily participate in the clinical study; fully understand and be informed about this study, and sign the informed consent form (ICF); willing to comply with and have the ability to complete all trial procedures. Male or female participants aged 18-75 (inclusive) at the time of signing the ICF. The case group included patients diagnosed with lung cancer, including early-stage and advanced-stage patients; the control group consisted of healthy individuals without a history of lung cancer or related respiratory diseases. At least one measurable target lesion evaluated according to RECIST 1.1 criteria by the Institutional Review and Research Committee (IRRC). Patients provide eligible tumor tissue for histopathological testing as required. Relevant laboratory tests indicate tolerance to chemotherapy and immunotherapy. Exclusion Criteria: Patients with unclear diagnosis of lung cancer. Patients with contraindications to chemotherapy or immunotherapy. Patients with contraindications to lung tissue examination. Patients with other respiratory diseases within the year or concurrent respiratory system diseases (such as chronic obstructive pulmonary disease, bronchial asthma, etc.). Patients with other active malignant tumors within the year or concurrently. Patients with severe heart disease and patients with other severe diseases (such as liver dysfunction, renal dysfunction, etc.). Patients known to have a history of psychiatric drug abuse or drug addiction; patients with a history of alcohol abuse. Based on the investigator's judgment, patients have other factors that may lead to premature termination of this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Time from randomization to death (from any cause) | From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months | 
| PFS | The time between the initiation of randomization and the occurrence (any aspect) of tumor progression or death (from any cause) | From date of diagnosis until the date of first documented progression from any cause, whichever came first, assessed up to 24 months | 
| ORR | 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 | 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 | 
| DOR | Is the time from the first documented response (CR or PR) to the first documented disease progression or death, whichever occurs first | The time from first diagnosis of CR or PR to diagnosis of PD was calculated at 24 months of study |