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Trial Title:
Development and Application of Molecular Evaluation Instrument for Lung Cancer Diagnosis and Treatment
NCT ID:
NCT06086587
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Biopsy patients in Shanghai Pulmonary Hospital
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. 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.
2. Male or female participants aged 18-75 (inclusive) at the time of signing the ICF.
3. 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.
4. At least one measurable target lesion evaluated according to RECIST 1.1 criteria by
the Institutional Review and Research Committee (IRRC).
5. Patients provide eligible tumor tissue for histopathological testing as required.
6. Relevant laboratory tests indicate tolerance to chemotherapy and immunotherapy.
Exclusion Criteria:
1. Patients with unclear diagnosis of lung cancer.
2. Patients with contraindications to chemotherapy or immunotherapy.
3. Patients with contraindications to lung tissue examination.
4. Patients with other respiratory diseases within the year or concurrent respiratory
system diseases (such as chronic obstructive pulmonary disease, bronchial asthma,
etc.).
5. Patients with other active malignant tumors within the year or concurrently.
6. Patients with severe heart disease and patients with other severe diseases (such as
liver dysfunction, renal dysfunction, etc.).
7. Patients known to have a history of psychiatric drug abuse or drug addiction;
patients with a history of alcohol abuse.
8. Based on the investigator's judgment, patients have other factors that may lead to
premature termination of this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
November 7, 2023
Completion date:
October 31, 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/NCT06086587
