Solitary Pulmonary NoduleNCT02773992
Clinical Study of Three Plus Two Type Early Diagnosis of Pulmonary Nodules in Medical Internet of Things
An observational study of Solitary Pulmonary Nodule, run by Henan Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solitary Pulmonary Nodule
- What is being tested?
- The IoT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single or multiple round solitary pulmonary nodules surrounded by lung parenchyma without associated atelectasis, diameter < 3 cm of small pulmonary nodules.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
XZhang
Zhengzhou, Henan
zhang xiaoju, 15837101166, 15837101166@163.com
liu haiyang, 18538312177, 371942956@qq.com
About this study
Official title: Multi Center Clinical Study of Three Plus Two Type Early Diagnosis of Pulmonary Nodules in Medical Internet of Things
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.
Read the 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.
- Conditions
- Solitary Pulmonary Nodule
- Being tested
- The IoT
- Keywords
- Solitary Pulmonary Nodule, Itos, lung cancer
- Medical subject headings
- Solitary Pulmonary Nodule, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The IoTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The IoT group | Not described Receives: Behavioral: The IoT | |
| The routine management group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The positive diagnosis rate of lung cancer in I stage
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startAug 2015
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary Pulmonary NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaoJu Zhang, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773992
- Sponsor's protocol ID
- 201501014
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center Clinical Study of Three Plus Two Type Early Diagnosis of Pulmonary Nodules in Medical Internet of Things
- ClinicalTrials.gov ID
- NCT02773992
- Acronym / sponsor ID
- 201501014
- Conditions
- Solitary Pulmonary Nodule
- Keywords
- Solitary Pulmonary Nodule, Itos, lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The IoT group | – | Behavioral: The IoT |
| The routine management group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single or multiple round solitary pulmonary nodules surrounded by lung parenchyma without associated atelectasis, diameter < 3 cm of small pulmonary nodules.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The IoTFor 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. | Behavioural | The IoT group |
Primary outcome
The positive diagnosis rate of lung cancer in I stage
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solitary Pulmonary Nodule, run by Henan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhang xiaoju (15837101166, 15837101166@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The positive diagnosis rate of lung cancer in I stage (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.