Lung CancerNCT06086587
Development and Application of Molecular Evaluation Instrument for Lung Cancer Diagnosis and Treatment
An observational study of Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2023to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Biopsy patients in Shanghai Pulmonary Hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Time from randomization to death (from any cause)
Measured: 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)
Measured: 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
Measured: 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
Measured: The time from first diagnosis of CR or PR to diagnosis of PD was calculated at 24 months of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start7 Nov 2023 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yayi He, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086587
- Sponsor's protocol ID
- 2022tjdxsy048
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28387927Kusano 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.
PubMed 21598081Jones 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.
PubMed 8590920Bruderer 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.
PubMed 31594311Zou 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.
PubMed 25171479
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of Molecular Evaluation Instrument for Lung Cancer Diagnosis and Treatment
- ClinicalTrials.gov ID
- NCT06086587
- Acronym / sponsor ID
- 2022tjdxsy048
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 7 Nov 2023 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Biopsy patients in Shanghai Pulmonary Hospital
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OS
Time frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months
Time from randomization to death (from any cause)
PFS
Time frame: From date of diagnosis until the date of first documented progression from any cause, whichever came first, assessed up to 24 months
The time between the initiation of randomization and the occurrence (any aspect) of tumor progression or death (from any cause)
ORR
Time frame: 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
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
DOR
Time frame: The time from first diagnosis of CR or PR to diagnosis of PD was calculated at 24 months of study
Is the time from the first documented response (CR or PR) to the first documented disease progression or death, whichever occurs first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 28387927Carozzi 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.
- Background: PubMed 21598081Kusano 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.
- Background: PubMed 8590920Jones 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.
- Background: PubMed 31594311Bruderer 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.
- Background: PubMed 25171479Zou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yayi He, PHD,MD (+86 021-65115006, doctorjael@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06086587, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.