Lung Cancer MetastaticNCT03179150
Clinical Validation of the M5L Lung CAD
An observational study of Lung Cancer Metastatic, run by Candiolo Cancer Institute - IRCCS at 1 site in Italy.
Trial summary
To compare the diagnostic performance and time efficiency of Computer-Aided Detection (CAD) assisted reading for the identification of pulmonary nodules in chest Computed Tomography (CT) from oncological patients with that of unassisted reading. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer Metastatic
- What is being tested?
- Computed Tomography
- How many people
- 237 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2015to 1 Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Between September 2015 and March 2016, 237 consecutive patients (123 men, 52%) with an average age of 62 (range 21-90 years), were enrolled in this retrospective observational single centre study. Patients enrolled into the study performed CT either for staging, restaging or follow-up of extrathoracic malignancies
Who may be able to join
- Diagnosed extra-thoracic neoplasm
Who cannot join
- More than 10 nodules
- Severe pulmonary fibrosis
- Diffuse bronchiectasis
- Extensive inflammatory consolidation
- Massive pleural effusion
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of a CAD System for the Automated Identification of Pulmonary Metastases in Oncological Patients - CADM5L
To compare the diagnostic performance and time efficiency of Computer-Aided Detection (CAD) assisted reading for the identification of pulmonary nodules in chest Computed Tomography (CT) from oncological patients with that of unassisted reading.
Read the detailed description
The main aim of this study is to compare the diagnostic performance of CAD assisted interpretation with that of unassisted reading in the detection of lung metastases in consecutive patients staged for extrathoracic malignancies. This study also aims at validating a new Web/Cloud based workflow for the use of CAD systems in clinical practice, not requiring installation of additional software or hardware and potentially representing a cost-effective CAD solution for clinical facilities.
- Conditions
- Lung Cancer Metastatic
- Being tested
- Computed Tomography
- Keywords
- computer-aided diagnosis, Web, Cloud computing, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyDiagnostic test
CT scans were performed on a 128 detector rows CT scanner (Somatom Definition Flash Siemens Medical Systems, Erlangen, Germany) as in routine clinical practice in the centre
| Study group | Role | What they receive |
|---|---|---|
| Oncological patients with extra-thoracic cancer | Patients enrolled into the study performed CT either for staging, restaging or follow-up of extrathoracic malignancies. Receives: Diagnostic Test: Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-patient detection sensitivity unassisted vs CAD assisted reading
Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per patient analysis
Measured: 1 month after collection of data
Per-lesion detection sensitivity unassisted vs CAD assisted reading
Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per-lesion analysis. Sub-analyses per nodule tissue, nodule dimension and nodule localization are included
Measured: 1 month after collection of data
Secondary outcomes (1)
Comparison of reading time between unassisted vs CAD assisted reading
Measured: 1 month after collection of data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Sep 2015
- Primary completion30 Mar 2016
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer MetastaticStudies 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
- Retrospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candiolo Cancer Institute - IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Traverso, Candiolo Cancer Institute - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179150
- Sponsor's protocol ID
- 35/2017 CADM5L
- Status last verified
- Jun 2017
- First submitted
- 6 Jun 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a CAD System for the Automated Identification of Pulmonary Metastases in Oncological Patients - CADM5L
- ClinicalTrials.gov ID
- NCT03179150
- Acronym / sponsor ID
- 35/2017 CADM5L
- Conditions
- Lung Cancer Metastatic
- Keywords
- computer-aided diagnosis, Web, Cloud computing, lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Candiolo Cancer Institute - IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 7 Jun 2017 (actual)
- 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.
To compare the diagnostic performance and time efficiency of Computer-Aided Detection (CAD) assisted reading for the identification of pulmonary nodules in chest Computed Tomography (CT) from oncological patients with that of unassisted reading.
Detailed description
The main aim of this study is to compare the diagnostic performance of CAD assisted interpretation with that of unassisted reading in the detection of lung metastases in consecutive patients staged for extrathoracic malignancies. This study also aims at validating a new Web/Cloud based workflow for the use of CAD systems in clinical practice, not requiring installation of additional software or hardware and potentially representing a cost-effective CAD solution for clinical facilities.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncological patients with extra-thoracic cancer | – | Diagnostic Test: Computed TomographyPatients enrolled into the study performed CT either for staging, restaging or follow-up of extrathoracic malignancies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Between September 2015 and March 2016, 237 consecutive patients (123 men, 52%) with an average age of 62 (range 21-90 years), were enrolled in this retrospective observational single centre study. Patients enrolled into the study performed CT either for staging, restaging or follow-up of extrathoracic malignancies
Key inclusion criteria (1 listed)
- Diagnosed extra-thoracic neoplasm
Key exclusion criteria (6 listed)
- More than 10 nodules
- Severe pulmonary fibrosis
- Diffuse bronchiectasis
- Extensive inflammatory consolidation
- Massive pleural effusion
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 |
|---|---|---|
| Computed TomographyCT scans were performed on a 128 detector rows CT scanner (Somatom Definition Flash Siemens Medical Systems, Erlangen, Germany) as in routine clinical practice in the centre | Diagnostic test | Oncological patients with extra-thoracic cancer |
Primary outcome
Per-patient detection sensitivity unassisted vs CAD assisted reading
Time frame: 1 month after collection of data
Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per patient analysis
Per-lesion detection sensitivity unassisted vs CAD assisted reading
Time frame: 1 month after collection of data
Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per-lesion analysis. Sub-analyses per nodule tissue, nodule dimension and nodule localization are included
1 secondary outcome
Comparison of reading time between unassisted vs CAD assisted reading
Time frame: 1 month after collection of data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer Metastatic, run by Candiolo Cancer Institute - IRCCS at 1 site in Italy.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 7 Jun 2017. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per-patient detection sensitivity unassisted vs CAD assisted reading (time frame: 1 month after collection of data). The study lists 2 primary outcomes in all. 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 7 Jun 2017.