ObjectiveTo investigate the predictive value of volatile organic compounds (VOCs) on pulmonary nodules in people aged less than 50 years.MethodsThe 147 patients with pulmonary nodules and aged less than 50 years who were treated in the Department of Thoracic Surgery of Sichuan Cancer Hospital from August 1, 2019 to January 15, 2020 were divided into a lung cancer group and a lung benign disease group. The lung cancer group included 36 males and 68 females, with the age of 27-49 (43.54±5.73) years. The benign lung disease group included 23 males and 20 females, with the age of 22-49 (42.49±6.83) years. Clinical data and exhaled breath samples were collected prospectively from the two groups. Exhaled breath VOCs were analyzed by gas chromatography mass spectrometry. Binary logistic regression analysis was used to select variables and establish a prediction model. The sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve of the prediction model were calculated.ResultsThere were statistically significant differences in sex (P=0.034), smoking history (P=0.047), cyclopentane (P=0.002), 3-methyl pentane (P=0.043) and ethylbenzene (P=0.009) between the two groups. The sensitivity, specificity and area under the ROC curve of the prediction model with gender, cyclopentane, 3-methyl pentane, ethylbenzene and N,N-dimethylformamide as variables were 80.8%, 60.5% and 0.781, respectively.ConclusionThe combination of VOCs and clinical characteristics has a certain predictive value for the benign and malignant pulmonary nodules in people aged less than 50 years.
The number of investigator initiated research (IIR) is increasing. But the recognition and management of IIR in China is still in its infancy, and there is a lack of specific and operable guidance for the implementation process. Based on our practical experiences, previous literature reports, and current policy regulations, the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps, which are as the following: study initiation, ethical review, study registration, study filing, case report form design, database establishment, standard operating procedure making, investigator training, informed consent, data collection, data entry, data verification, data locking and data archiving.