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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04892524




Registration number
NCT04892524
Ethics application status
Date submitted
7/05/2021
Date registered
19/05/2021

Titles & IDs
Public title
Virtual Management of Lung Nodules
Scientific title
Investigation Into the Identification, Management and Follow-up of Incidental Lung Nodules.
Secondary ID [1] 0 0
SALHNLungNodules
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Nodule, Solitary 0 0
Pulmonary Nodule, Multiple 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Virtual multidisciplinary review

Experimental: Virtual multidisciplinary review - Participants in this arm will be reviewed in a virtual clinic by a multidisciplinary team

No intervention: Face-to-face review - Participants in this group will be reviewed in a face-to-face clinic


Other interventions: Virtual multidisciplinary review
The virtual multidisciplinary review involves participants being reviewed by a multi-disciplinary team of specialist doctors, nurses and radiologists in a virtual environment. The team will analyse radiologic scans and make a recommendations for any follow-up scans, procedures or appointments that may be required

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cost
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Participant satisfaction
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Anxiety
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
* Age 18-80 years
* At least 1 IPN identified on CT imaging measuring 4-30 mm in maximal diameter
* CT slice thickness of 3 mm or less
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous diagnosis of lung cancer
* History of haemoptysis
* Unexplained weight loss > 7 kg in the preceding 12 months
* Past history of malignancy within 5 years (excluding non-melanoma skin cancer)

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park

Funding & Sponsors
Primary sponsor type
Other
Name
Southern Adelaide Local Health Network
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anand Rose
Address 0 0
Southern Adelaide Local Health Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.