Clinical trial NCT06086587: Development and Application of Molecular Evaluation Instrument for Lung Cancer Diagnosis and Treatment
Official title: Development and Application of Molecular Evaluation Instrument for Lung Cancer Diagnosis and Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biopsy patients in Shanghai Pulmonary Hospital

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.


Eligibility 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.

Primary outcomes:
measure: OS
timeFrame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months
measure: PFS
timeFrame: From date of diagnosis until the date of first documented progression from any cause, whichever came first, assessed up to 24 months
measure: ORR
timeFrame: 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
measure: DOR
timeFrame: The time from first diagnosis of CR or PR to diagnosis of PD was calculated at 24 months of study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Carozzi FM, Bisanzi S, Carrozzi L, Falaschi F, Lopes Pegna A, Mascalchi M, Picozzi G, Peluso M, Sani C, Greco L, Ocello C, Paci E; ITALUNG Working Group. Multimodal lung cancer screening using the ITALUNG biomarker panel and low dose computed tomography. Results of the ITALUNG biomarker study. Int J Cancer. 2017 Jul 1;141(1):94-101. doi: 10.1002/ijc.30727. Epub 2017 Apr 21.
citation: Kusano M, Mendez E, Furton KG. Development of headspace SPME method for analysis of volatile organic compounds present in human biological specimens. Anal Bioanal Chem. 2011 Jun;400(7):1817-26. doi: 10.1007/s00216-011-4950-2. Epub 2011 Apr 6.
citation: Jones AW, Lagesson V, Tagesson C. Determination of isoprene in human breath by thermal desorption gas chromatography with ultraviolet detection. J Chromatogr B Biomed Appl. 1995 Oct 6;672(1):1-6. doi: 10.1016/0378-4347(95)00207-y.
citation: Bruderer T, Gaisl T, Gaugg MT, Nowak N, Streckenbach B, Muller S, Moeller A, Kohler M, Zenobi R. On-Line Analysis of Exhaled Breath Focus Review. Chem Rev. 2019 Oct 9;119(19):10803-10828. doi: 10.1021/acs.chemrev.9b00005. Epub 2019 Aug 21.
citation: Zou Y, Zhang X, Chen X, Hu Y, Ying K, Wang P. Optimization of volatile markers of lung cancer to exclude interferences of non-malignant disease. Cancer Biomark. 2014;14(5):371-9. doi: 10.3233/CBM-140418.