A Prospective, Non-interventional Cohort Study of Subsolid Pulmonary Nodules
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuangdong Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Patients with subsolid pulmonary nodules of 5 to 30 mm in size found on CT
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
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 yearsSecondary outcomes
1
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
Time frame
The time from patient enrollment and initiation of follow-up until invasive diagnosis/intervention2
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
Time frame
From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up3
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
Time frame
From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up4
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
Time frame
From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangdong Provincial People's Hospital
Lead sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborator
Peking University People's Hospital
Collaborator
Guangxi Medical University
Collaborator
Shanghai Zhongshan Hospital
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborator
The Third People's Hospital of Chengdu
Collaborator
Shantou Central Hospital
Collaborator
Hainan Cancer Hospital
Collaborator
Shenzhen People's Hospital
Collaborator
Hunan Cancer Hospital
Collaborator
Shenzhen Third People's Hospital
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
Haikou People's Hospital
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: