Adenocarcinoma of LungNCT06215885
Multi-omics Analysis to Characterize the Invasive Evolution of Pulmonary Subsolid Nodules
An observational study of Adenocarcinoma of Lung, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Current clinical follow-up frequency and treatment timing for pulmonary subsolid nodules (SSNs) rely mostly on whether the nodules grow, which may not accurately reflect the pathological status, and may lead to unnecessary follow-ups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of Lung
- What is being tested?
- Mass spectrometry-based proteomics
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2024to Dec 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients who underwent chest CT examination and found SSN and planned to undergo surgical treatment from November 2023 to September 2024 and Healthy volunteers.
Who may be able to join
- Patients with SSNs
- Newly diagnosed patients with persistent SSNs confirmed by thin-section chest CT examination
- Patient areilling to undergo surgery
- Voluntarily sign a written informed consent form
- Healthy Volunteers
- Healthy volunteers aged 18-50 years, regardless of gender.
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- No lung nodules detected on chest thin-section CT.
- No history of cancer.
- Voluntary sign a written informed consent form.
Who cannot join
- Patients with SSNs
- Surgical contraindications
- Inability to cooperate with CT/MR examination to obtain high-quality images
- History of malignant tumors
- Previous targeted, immune, or ablation therapy
- Postoperative pathology of non-lung adenocarcinoma disease spectrum
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- Other situations deemed unsuitable for participation in this study by the researchers
- Healthy Volunteers
- Drug abuse
- HIV infection or AIDS
- History of syphilis, gonorrhea, or other infectious diseases
- Hepatitis B or C virus carrier
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Li Zhang, Doctor, 15010225989, zhangli_cicams@163.com
About this study
Official title: Cancer Hospital Chinese Academy of Medical Sciences
Current clinical follow-up frequency and treatment timing for pulmonary subsolid nodules (SSNs) rely mostly on whether the nodules grow, which may not accurately reflect the pathological status, and may lead to unnecessary follow-ups. This study aims to use multi-omics techniques to dynamically observe the growth and invasiveness evolution process of SSNs and uncover its invasiveness mechanism. Radiological characteristics of SSNs in different invasiveness stages were also analyzed and summarized by analyzing preoperative CT. This can overcome the bottleneck of invasiveness assessment in the growth process of SSN and provide scientific evidence for the scientific management and clinical treatment timing choice of SSN patients, thus facilitating the rational allocation of medical resources and prolonging the expected survival of national health.
Read the detailed description
This prospective observational cohort study aims to recruit 120 patients with subsolid nodules (SSNs) and 100 healthy volunteers. Enroll 120 patients with SSNs planned for surgery and 100 healthy volunteers. Sequence blood and tissue samples from patients and compare the relevance of biomarkers between the two. Use blood from healthy volunteers as blank controls. Additionally, analyzes radiological characteristics of SSNs at different invasive stages using preoperative CT.
- Conditions
- Adenocarcinoma of Lung
- Being tested
- Mass spectrometry-based proteomics
- Keywords
- Subsolid nodule, Invasive evolution
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mass spectrometry-based proteomicsDiagnostic test
Also called Phosphoproteomics, Deep-profiling tyrosine phosphorylation proteomics, Plasma proteomics, Plasma genomics
Detecting genomic and proteomic information
| Study group | Role | What they receive |
|---|---|---|
| Subsolid nodules group | Patients with pulmonary subsolid nodules were identified by CT examination and intended for surgical treatment. All participants will undergo chest CT, genomic, and proteomic tests to identify related biomarkers and establish a clinical diagnostic model for the invasiveness of subsolid nodules. Receives: Diagnostic Test: Mass spectrometry-based proteomics | |
| Volunteers group | Healthy volunteers. Receives: Diagnostic Test: Mass spectrometry-based proteomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of subsolid nodule invasive diagnosis
The efficacy of screening features for SSN invasiveness was compared to pathological diagnosis, using metrics such as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start22 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of LungStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215885
- Sponsor's protocol ID
- NCC4258
- Status last verified
- Oct 2023
- First submitted
- 1 Jan 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Hospital Chinese Academy of Medical Sciences
- ClinicalTrials.gov ID
- NCT06215885
- Acronym / sponsor ID
- NCC4258
- Conditions
- Adenocarcinoma of Lung
- Keywords
- Subsolid nodule, Invasive evolution
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Jan 2024 (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.
Current clinical follow-up frequency and treatment timing for pulmonary subsolid nodules (SSNs) rely mostly on whether the nodules grow, which may not accurately reflect the pathological status, and may lead to unnecessary follow-ups. This study aims to use multi-omics techniques to dynamically observe the growth and invasiveness evolution process of SSNs and uncover its invasiveness mechanism. Radiological characteristics of SSNs in different invasiveness stages were also analyzed and summarized by analyzing preoperative CT. This can overcome the bottleneck of invasiveness assessment in the growth process of SSN and provide scientific evidence for the scientific management and clinical treatment timing choice of SSN patients, thus facilitating the rational allocation of medical resources and prolonging the expected survival of national health.
Detailed description
This prospective observational cohort study aims to recruit 120 patients with subsolid nodules (SSNs) and 100 healthy volunteers. Enroll 120 patients with SSNs planned for surgery and 100 healthy volunteers. Sequence blood and tissue samples from patients and compare the relevance of biomarkers between the two. Use blood from healthy volunteers as blank controls. Additionally, analyzes radiological characteristics of SSNs at different invasive stages using preoperative CT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subsolid nodules group | – | Diagnostic Test: Mass spectrometry-based proteomicsPatients with pulmonary subsolid nodules were identified by CT examination and intended for surgical treatment. All participants will undergo chest CT, genomic, and proteomic tests to identify related biomarkers and establish a clinical diagnostic model for the invasiveness of subsolid nodules. |
| Volunteers group | – | Diagnostic Test: Mass spectrometry-based proteomicsHealthy volunteers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent chest CT examination and found SSN and planned to undergo surgical treatment from November 2023 to September 2024 and Healthy volunteers.
Key inclusion criteria (9 listed)
- Patients with SSNs
- Newly diagnosed patients with persistent SSNs confirmed by thin-section chest CT examination
- Patient areilling to undergo surgery
- Voluntarily sign a written informed consent form
- Healthy Volunteers
Key exclusion criteria (12 listed)
- Patients with SSNs
- Surgical contraindications
- Inability to cooperate with CT/MR examination to obtain high-quality images
- History of malignant tumors
- Previous targeted, immune, or ablation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mass spectrometry-based proteomicsAlso: Phosphoproteomics, Deep-profiling tyrosine phosphorylation proteomics, Plasma proteomics, Plasma genomicsDetecting genomic and proteomic information | Diagnostic test | Subsolid nodules group, Volunteers group |
Primary outcome
Accuracy of subsolid nodule invasive diagnosis
Time frame: Through study completion, an average of 1 year.
The efficacy of screening features for SSN invasiveness was compared to pathological diagnosis, using metrics such as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- 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.
Li Zhang, Doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma of Lung, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in 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 9 inclusion and 12 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 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Li Zhang, Doctor (15010225989, zhangli_cams@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of subsolid nodule invasive diagnosis (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2024.