- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02773992
Clinical Study of Three Plus Two Type Early Diagnosis of Pulmonary Nodules in Medical Internet of Things
Multi Center Clinical Study of Three Plus Two Type Early Diagnosis of Pulmonary Nodules in Medical Internet of Things
Study Overview
Detailed Description
The flow chart of the study design is shown in Figure 1.After enrollment, participants are randomly assigned into two groups: the IoT group and the routine management group. For both groups, participants are gathered basic information (age, sex, smoking and smoking status, family history of cancer, family history of lung disease,Other malignant tumor history, drug using history and its effect during a fever). For the IoT group, "three plus two type pulmonary nodule diagnosis" which professor Bai put forward is carried out on participants: three basic steps: 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 participants: 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 participants scientifically in accordance with the follow-up management tables through the Internet of things platform (Researchkit). The routine management group are completely managed by investigators' personal experience.
Follow-up Researchkit APP based on the android phone system and IOS system is installed in the participant's cellphone for free and all participant are trained to use the software. They are allowed to practice until accurate data submission and collection are ascertained. At the same time, an APP instruction is also provided, with one engineer ready for consultation in case of any technical problems. The following measures are carried out via the Internet platform: ① collect the basic information of the subjects, suggest the date of follow-up according to the the subjects' nodule situation; ② health education is pushed to the subjects' mobile terminal to help them carry out self health management; ③ subjects are asked to report their physical conditions once a month via Researchkit APP; ④ communication with medical staff during work hours is available remotely through the mobile device.
Participant are allowed to make unscheduled clinic visits and emergency visits as necessary. The study period is 5 years. The outcomes will be recorded and the superiority of "iot three plus two diagnosis method" in the management of pulmonary nodules will be evaluated.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: zhang xiaoju
- Phone Number: 15837101166
- Email: 15837101166@163.com
Study Contact Backup
- Name: liu haiyang
- Phone Number: 18538312177
- Email: 371942956@qq.com
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China
- Recruiting
- XZhang
-
Contact:
- zhang xiaoju
- Phone Number: 15837101166
- Email: 15837101166@163.com
-
Contact:
- liu haiyang
- Phone Number: 18538312177
- Email: 371942956@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Subjects must meet the following criteria:
Inclusion Criteria:
- 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.
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
The IoT group
|
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 routine management group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The positive diagnosis rate of lung cancer in I stage
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201501014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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