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Status unknownNCT06086587Updated Oct 17, 2023

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

An observational study in Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Status unknown. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Lung Cancer

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In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's planned enrollment of 500 is above the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 157 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Biopsy patients in Shanghai Pulmonary Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. OS

    Time from randomization to death (from any cause)

    Time frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months

  2. PFS

    The time between the initiation of randomization and the occurrence (any aspect) of tumor progression or death (from any cause)

    Time frame: From date of diagnosis until the date of first documented progression from any cause, whichever came first, assessed up to 24 months

  3. 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

    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

  4. DOR

    Is the time from the first documented response (CR or PR) to the first documented disease progression or death, whichever occurs first

    Time frame: The time from first diagnosis of CR or PR to diagnosis of PD was calculated at 24 months of study

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Study locations

No study locations are listed for this record.

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References and documents

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 28387927 ↗
  • 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. PubMed 21598081 ↗
  • 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. PubMed 8590920 ↗
  • 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. PubMed 31594311 ↗
  • 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. PubMed 25171479 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2023; primary completion for Oct 2024, 11 months later.

Of 578 non-industry observational studies under Lung Neoplasms, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 172. This study's planned 11 months is below that.

Counting every sponsor, half of 685 studies reached it within 56 months; a quarter within 29 and three quarters within 130.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2023
First posted
Oct 17, 2023
StartEst.
Nov 7, 2023
Primary completionEst.
Oct 31, 2024
CompletionEst.
Oct 31, 2025
Last update
Oct 17, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06086587
Responsible party
Yayi He (Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China) — Principal investigator
First posted
Oct 17, 2023
Start date
Nov 7, 2023 (estimated)
Primary completion
Oct 31, 2024 (estimated)
Completion
Oct 31, 2025 (estimated)
Last update
Oct 17, 2023

Study contacts

Yayi He, PHD,MD
Contact
doctorjael@qq.com
+86 021-65115006

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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