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

NCT02773992 | Unknown

• 1 other identifier: 201501014
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Solitary Pulmonary Nodule; Itos; lung cancer

Outcome Measures

Primary Outcomes (1)

• The positive diagnosis rate of lung cancer in I stage

  5 years

Study Arms (2)

The IoT group

Behavioral: The IoT

The routine management group

Interventions

The IoT BEHAVIORAL

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.

The IoT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Single or multiple round solitary pulmonary nodules surrounded by lung parenchyma without associated atelectasis, diameter \< 3 cm of small pulmonary nodules.

You may qualify if:

• Over 18 years old;
• Single or multiple round solitary pulmonary nodules surrounded by lung parenchyma without associated atelectasis, diameter \< 3 cm of small pulmonary nodules;
• Patients should be capable of reading and writing Chinese, without impaired verbal communication;
• Patients should be capable of using intellectual equipment.

You may not qualify if:

• Chest CT present lung mass, large seepage or atelectasis;
• Other active chronic respiratory system diseases needing be diagnosed , intervention and treatment;
• Severe or uncontrolled complications of other systems;
• Complicated with pleural effusion;
• Patients with cognitive impairment or mental abnormalities being unable to complete the questionnaire.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

XZhang

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

zhang xiaoju

CONTACT

15837101166; 15837101166@163.com

liu haiyang

CONTACT

18538312177; 371942956@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 16, 2016
• Study Start: August 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: May 16, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)