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Clinical Study of Three Plus Two Type Early Diagnosis of Pulmonary Nodules in Medical Internet of Things

NCT02773992 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2016-05-16

No results posted yet for this study

Summary

Medical The Internet of Things (IoT), a recent breakthrough in communication technology, could be helpful in improving health care delivery and saving medical costs, but regarding pulmonary nodule management it is still at the basic understanding. Investigators adopt "Internet of things medical three plus two type pulmonary nodule diagnosis" which chun-xue Bai put forward, used a developed a mobile phone-based IoT (mIoT) platform and initiated a randomized, multicenter, controlled trial to value clinical effectivity of "Internet of things medical three plus two type pulmonary nodule diagnosis" in the management of pulmonary nodules. In this study, at least 600 patients with pulmonary nodules (no typical symptoms, often single, clear boundary, increased density, soft tissue shadow surrounded by lung parenchyma with diameter ≤3 cm) will be randomly allocated to the control group, which receives routine follow-up, or the intervention group, which receives "Internet of things medical three plus two type pulmonary nodule diagnosis" management. Endpoints of the study include: (1) The positive diagnosis rate of lung cancer in I stage; (2) 5 year disease-free survival rate and overall survival rate; (3) direct medical costs per year. Results from this study should provide direct evidence for the suitability of "Internet of things medical three plus two type pulmonary nodule diagnosis" in pulmonary nodules patients management.

Conditions

  • Solitary Pulmonary Nodule

Interventions

BEHAVIORAL

The IoT

For the IoT group, "three plus two type pulmonary nodule diagnosis"： ① gather information: smoking history, tumor personal and family history, copd history, etc.; ② noninvasive examination: tumor markers, lung function and chest low-dose CT thin layer; ③ information mining in-depth:through the software for three-dimensional reconstruction of pulmonary nodules, depth excavation, accurate calculation of the density of the volume, assessment of the surrounding and infiltration of lung nodules and related vascular growth status; two solutions: ① Pathological diagnosis in highly suspected patients: fiber bronchoscope, ultrasonic bronchoscope, thoracoscope and CT guided percutaneous lung biopsy, etc.; ② Close scientific follow-up to the person who can not be qualitative: doctors follow up and manage patients scientifically in accordance with the follow-up management tables through the Internet of things platform.

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02773992 on ClinicalTrials.gov