Solitary Lung NoduleNCT06458673
A Prospective, Non-interventional Cohort Study of Subsolid Pulmonary Nodules
An observational study of Solitary Lung Nodule and Multiple Pulmonary Nodules, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Some studies have shown that the model for judging and predicting the growth of sub-solid pulmonary nodules through big data and deep learning can detect nodule growth earlier. Since most of the training data come from large foreign samples, most of the validated data are CT data from a single center or a few centers… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solitary Lung Nodule, Multiple Pulmonary Nodules
- How many people
- 1,184 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Nov 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with subsolid pulmonary nodules of 5 to 30 mm in size found on CT
Who may be able to join
- Age≥ 18 years old, gender is not limited
- Confirmed subsolid pulmonary nodule by CT, initial pulmonary nodule ≥ 5 mm (including subsolid components) and ≤ 30 mm, do not shrink or disappear after 3 months Follow-up.
- ECOG 0～2
- Able to provide CT in DICOM format
- Informed consent obtained
Who cannot join
- Long-term use of immunosuppressants and hormone drugs
- History of previous malignancy (if there is no recurrence or carcinoma in situ for more than 5 years after receiving curative therapy, it can be enrolled)
- Inability to cooperate with regular follow-up
- Poor general condition, with the life expectancy less than 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Xuening Yang, MD, 0086-13922713300, yangxncn@qq.com
About this study
Official title: Prediction of Growth Trend of Pulmonary Nodules Based on Multi-temporal and Multimodal Medical Data and Its Impact on Pulmonary Nodule Management Strategies
Some studies have shown that the model for judging and predicting the growth of sub-solid pulmonary nodules through big data and deep learning can detect nodule growth earlier. Since most of the training data come from large foreign samples, most of the validated data are CT data from a single center or a few centers, and their generalization ability needs to be further verified. In order to better study subsolid pulmonary nodules in the lungs in China, we plan to conduct a prospective, multicenter, non-interventional observational cohort study.
Read the detailed description
Through the follow-up of pulmonary nodules, artificial intelligence based on CT was used to study the natural evolution process of subsolid pulmonary nodules, as well as the development law and prognosis of pulmonary subsolid nodules under treatment or no treatment according to clinical guidelines.
- Conditions
- Solitary Lung Nodule, Multiple Pulmonary Nodules
- Keywords
- Lung Nodule, Prospective, Observational Study
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year growth rate of subsolid pulmonary nodules
The 5-year growth rate of the nodules is calculated by comparing the initial and final diameters of the nodules during the follow-up period.Results are expressed as percentages.
Measured: Regular follow-up was carried out according to clinical guidelines and local hospital guidelines, with an interval of 3-6 months and a duration of 5 years
Secondary outcomes (4)
Median time from enrollment to invasive diagnosis/intervention in patients with subsolid pulmonary nodules
Median length of time from patient enrollment to invasive diagnosis or therapeutic intervention such as surgical excision, biopsy, or other therapeutic procedures
Measured: The time from patient enrollment and initiation of follow-up until invasive diagnosis/intervention
Lung cancer-specific 5-year survival rate
Lung cancer-specific 5-year survival rate is defined as a proportion of patients diagnosed with lung cancer who survive within 5 years of diagnosis
Measured: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up
explore the growth rate and pattern of radiographic changes of different types of pulmonary nodules
the growth rate is calculated by comparing the initial and final diameters of the nodules during the follow-up period. Results are expressed as 1mm/year
Measured: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up
Sensitivity and specificity of radiomics in predicting the growth of subsolid pulmonary nodules
the sensitivity and specificity is calculated by comparing the predicted results and the real results
Measured: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary Lung NoduleStudies of the same condition, open and under way.
- 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
- 1,184 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, Peking University People's Hospital, Guangxi Medical University, Shanghai Zhongshan Hospital, The Third Xiangya Hospital of Central South University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, The Third People's Hospital of Chengdu, Shantou Central Hospital, Hainan Cancer Hospital, Shenzhen People's Hospital, Hunan Cancer Hospital, Shenzhen Third People's Hospital, First Affiliated Hospital of Jinan University, Haikou People's Hospital, Second Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Xue-Ning Yang, Guangdong Provincial People's Hospital
- Investigators
- Xuening Yang, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458673
- Sponsor's protocol ID
- CONAN
- Status last verified
- Nov 2024
- First submitted
- 9 Jun 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Growth Trend of Pulmonary Nodules Based on Multi-temporal and Multimodal Medical Data and Its Impact on Pulmonary Nodule Management Strategies
- ClinicalTrials.gov ID
- NCT06458673
- Acronym / sponsor ID
- CONAN
- Conditions
- Solitary Lung Nodule, Multiple Pulmonary Nodules
- Keywords
- Lung Nodule, Prospective, Observational Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,184 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, Peking University People's Hospital, Guangxi Medical University, Shanghai Zhongshan Hospital, The Third Xiangya Hospital of Central South University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, The Third People's Hospital of Chengdu, Shantou Central Hospital, Hainan Cancer Hospital, Shenzhen People's Hospital, Hunan Cancer Hospital, Shenzhen Third People's Hospital, First Affiliated Hospital of Jinan University, Haikou People's Hospital, Second Affiliated Hospital of Guangzhou Medical University
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 13 Jun 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.
Some studies have shown that the model for judging and predicting the growth of sub-solid pulmonary nodules through big data and deep learning can detect nodule growth earlier. Since most of the training data come from large foreign samples, most of the validated data are CT data from a single center or a few centers, and their generalization ability needs to be further verified. In order to better study subsolid pulmonary nodules in the lungs in China, we plan to conduct a prospective, multicenter, non-interventional observational cohort study.
Detailed description
Through the follow-up of pulmonary nodules, artificial intelligence based on CT was used to study the natural evolution process of subsolid pulmonary nodules, as well as the development law and prognosis of pulmonary subsolid nodules under treatment or no treatment according to clinical guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subsolid pulmonary nodules of 5 to 30 mm in size found on CT
Key inclusion criteria (5 listed)
- Age≥ 18 years old, gender is not limited
- Confirmed subsolid pulmonary nodule by CT, initial pulmonary nodule ≥ 5 mm (including subsolid components) and ≤ 30 mm, do not shrink or disappear after 3 months Follow-up.
- ECOG 0～2
- Able to provide CT in DICOM format
- Informed consent obtained
Key exclusion criteria (4 listed)
- Long-term use of immunosuppressants and hormone drugs
- History of previous malignancy (if there is no recurrence or carcinoma in situ for more than 5 years after receiving curative therapy, it can be enrolled)
- Inability to cooperate with regular follow-up
- Poor general condition, with the life expectancy less than 6 months
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
5-year growth rate of subsolid pulmonary nodules
Time frame: Regular follow-up was carried out according to clinical guidelines and local hospital guidelines, with an interval of 3-6 months and a duration of 5 years
The 5-year growth rate of the nodules is calculated by comparing the initial and final diameters of the nodules during the follow-up period.Results are expressed as percentages.
4 secondary outcomes
Median time from enrollment to invasive diagnosis/intervention in patients with subsolid pulmonary nodules
Time frame: The time from patient enrollment and initiation of follow-up until invasive diagnosis/intervention
Lung cancer-specific 5-year survival rate
Time frame: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up
explore the growth rate and pattern of radiographic changes of different types of pulmonary nodules
Time frame: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up
Sensitivity and specificity of radiomics in predicting the growth of subsolid pulmonary nodules
Time frame: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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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.
Xuening Yang, MD principal investigator
Guangdong Provincial People's Hospital
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 Solitary Lung Nodule and Multiple Pulmonary Nodules, run by Guangdong Provincial People's Hospital 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuening Yang, MD (0086-13922713300, yangxncn@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year growth rate of subsolid pulmonary nodules (time frame: Regular follow-up was carried out according to clinical guidelines and local hospital guidelines, with an interval of 3-6 months and a duration of 5 years). 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 2 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.