An observational study in Pulmonary Nodules, Lung Neoplasms and Artificial Intelligence (AI), sponsored by Shanghai East Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Shanghai East Hospital · Observational
This is an observational, multicentre study. The primary objective of this study was to evaluate the diagnostic performance and clinical applicability of artificial intelligence models for pulmonary nodule segmentation, benign-malignant risk stratification, and follow-up management. We will collect CT images and medical data from participants at several hospitals. Participants will not receive any drugs or medical interventions.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's planned enrollment of 16,880 is above the median of 255 across 51 observational studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →Shanghai East Hospital is the lead sponsor of 95 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutively enrolled, representative patients (aged ≥18 years, with a maximum nodule diameter of ≥3 mm and ≤30 mm) who underwent chest CT for routine clinical care and were found to have pulmonary nodules, including solid, part-solid, and pure ground-glass nodules.
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.
(1) Age ≥18 years; (2) At least one non-calcified pulmonary nodule (diameter ≥3 mm and ≤30 mm) detected on chest CT; (3) Agreement to participate in the study and provision of written .
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with pulmonary nodules diagnosed as benign, confirmed by either pathological examination or stability on follow-up imaging. No intervention is applied.
Participants with pulmonary nodules diagnosed as malignant, confirmed by pathological examination. No intervention is applied.
Diagnostic performance of the AI model for pulmonary nodule malignancy
Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the AI model for classifying benign and malignant nodules, using pathology results or longitudinal stability as the reference standard.
Time frame: Up to 24 months after enrollment
Risk stratification accuracy across different nodule sizes
The ability of the AI model to correctly stratify nodules into low, intermediate, and high-risk categories compared to clinical judgement.
Time frame: Up to 24 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
Of 24 observational studies under Multiple Pulmonary Nodules, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 62. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Shanghai East Hospital