Solitary Pulmonary Nodule Clinical Trial
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT05066776 -
Liquid Biopsy With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules
|
||
Completed |
NCT01958931 -
Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
|
N/A | |
Recruiting |
NCT03528733 -
Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection
|
N/A | |
Recruiting |
NCT02693496 -
Mobile Lung Nodule Observatory for Worldwide, Evidenced-based Research
|
||
Completed |
NCT01566682 -
A Multi-Center Trial of the ProLung Test™
|
||
Terminated |
NCT02983903 -
Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions
|
N/A | |
Terminated |
NCT02050724 -
ThoHSpEkt Thoracoscopic Ectomy of Radioactively Marked Pulmonary Nodules With Free-hand SPECT
|
Phase 2 | |
Not yet recruiting |
NCT04615156 -
18F-2-fluoro-2-deoxy-D-glucose in Positron Emission Tomography Computed Tomography
|
Phase 3 | |
Recruiting |
NCT02726633 -
Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer
|
N/A | |
Active, not recruiting |
NCT02623712 -
The Watch the Spot Trial
|
N/A | |
Recruiting |
NCT03568799 -
4-[18F]Fluoroglutamine PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
|
N/A | |
Not yet recruiting |
NCT02817048 -
Tubeless VATS for Peripheral Lung Nodule
|
N/A | |
Recruiting |
NCT01149187 -
Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules
|
N/A | |
Completed |
NCT00925210 -
Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach
|
Phase 2 | |
Completed |
NCT02448225 -
18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
|
Phase 2 | |
Active, not recruiting |
NCT05171491 -
LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
|
||
Terminated |
NCT04140474 -
Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.
|
N/A | |
Withdrawn |
NCT05804435 -
iNod™ Ultrasound-Guided Needle Biopsy System Study
|
N/A | |
Not yet recruiting |
NCT02653859 -
Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells in Benign and Malignant Lung Nodules
|
N/A | |
Completed |
NCT02832284 -
iNod System Human Feasibility Assessment
|
N/A |