Nonsmall Cell Lung CancerNCT03940846
CT-based Radiomic Signature Can Identify Adenocarcinoma Lung Tumor Histology
An observational study of Nonsmall Cell Lung Cancer, run by Maastricht University at 1 site in Netherlands.
Trial summary
Lung cancer remains the leading cause of cancer related mortality worldwide, with more than 1.5 million related deaths annually. Lung cancer is divided into two main groups: Small Cell Lung Carcinoma (SCLC) and Non-Small Cell Lung Carcinoma (NSCLC), with prevalence of ~20% and 80% respectively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nonsmall Cell Lung Cancer
- What is being tested?
- Virtual biopsy
- How many people
- 650 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2019to 31 Jan 2021
- 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: Patients diagnosed with NSCLC, who further underwent tissue biopsy to determine tumor histology.
Who may be able to join
- Availability of diagnostic non-contrast enhanced CT scan.
- Availability of histologic tumor analysis results
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Lung cancer remains the leading cause of cancer related mortality worldwide, with more than 1.5 million related deaths annually. Lung cancer is divided into two main groups: Small Cell Lung Carcinoma (SCLC) and Non-Small Cell Lung Carcinoma (NSCLC), with prevalence of ~20% and 80% respectively. NSCLC is further subdivided into adenocarcinoma (the most common), squamous cell carcinoma (SCC), and large cell carcinoma. Furthermore, each subtype is likely to have specific mutations, which could be targeted for treatment.
Medical imaging and radiomics feature extraction represent a candidate alternative to conventional tissue biopsy, a theory that is investigated in this study.
- Conditions
- Nonsmall Cell Lung Cancer
- Being tested
- Virtual biopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual biopsyDiagnostic test
Also called Radiomics-based histology prediction
Radiomics -the high throughput extraction of quantitative features from medical imaging- extract features that might potentially decode biologic tumor information, which might ultimately reduce the need to use invasive procedure, such as tissue biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Maastro (Lung1) | Open source dataset available at TCIA.org. The cohort includes CT scans of 422 patients diagnosed with NSCLC. Receives: Diagnostic Test: Virtual biopsy | |
| UCSF | A cohort of patients diagnosed with NSCLC at UCSF medical center. It includes CT scans of 165 patients. Receives: Diagnostic Test: Virtual biopsy | |
| Radboud | A cohort of patients diagnosed with NSCLC at Radboud medical center. It includes CT scans of 255 patients. Receives: Diagnostic Test: Virtual biopsy | |
| Stanford | Open source dataset available at TCIA.org. The cohort includes CT scans of 211 patients diagnosed with NSCLC. Receives: Diagnostic Test: Virtual biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung histology
Is the tumor under investigation an adenocarcinoma of the lung?
Measured: December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Mar 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall Cell Lung CancerStudies 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
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940846
- Sponsor's protocol ID
- LHist
- Status last verified
- Apr 2019
- First submitted
- 6 May 2019
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-based Radiomic Signature Can Identify Adenocarcinoma Lung Tumor Histology
- ClinicalTrials.gov ID
- NCT03940846
- Acronym / sponsor ID
- LHist
- Conditions
- Nonsmall Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Radboud University Medical Center
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 7 May 2019 (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.
Lung cancer remains the leading cause of cancer related mortality worldwide, with more than 1.5 million related deaths annually. Lung cancer is divided into two main groups: Small Cell Lung Carcinoma (SCLC) and Non-Small Cell Lung Carcinoma (NSCLC), with prevalence of ~20% and 80% respectively. NSCLC is further subdivided into adenocarcinoma (the most common), squamous cell carcinoma (SCC), and large cell carcinoma. Furthermore, each subtype is likely to have specific mutations, which could be targeted for treatment.
Medical imaging and radiomics feature extraction represent a candidate alternative to conventional tissue biopsy, a theory that is investigated in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Maastro (Lung1) | – | Diagnostic Test: Virtual biopsyOpen source dataset available at TCIA.org. The cohort includes CT scans of 422 patients diagnosed with NSCLC. |
| UCSF | – | Diagnostic Test: Virtual biopsyA cohort of patients diagnosed with NSCLC at UCSF medical center. It includes CT scans of 165 patients. |
| Radboud | – | Diagnostic Test: Virtual biopsyA cohort of patients diagnosed with NSCLC at Radboud medical center. It includes CT scans of 255 patients. |
| Stanford | – | Diagnostic Test: Virtual biopsyOpen source dataset available at TCIA.org. The cohort includes CT scans of 211 patients diagnosed with NSCLC. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with NSCLC, who further underwent tissue biopsy to determine tumor histology.
Key inclusion criteria (2 listed)
- Availability of diagnostic non-contrast enhanced CT scan.
- Availability of histologic tumor analysis results
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Virtual biopsyAlso: Radiomics-based histology predictionRadiomics -the high throughput extraction of quantitative features from medical imaging- extract features that might potentially decode biologic tumor information, which might ultimately reduce the need to use invasive procedure, such as tissue biopsy. | Diagnostic test | Maastro (Lung1), Radboud, Stanford, UCSF |
Primary outcome
Lung histology
Time frame: December 2019
Is the tumor under investigation an adenocarcinoma of the lung?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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 Nonsmall Cell Lung Cancer, run by Maastricht University at 1 site in Netherlands.
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 2 inclusion and 1 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 6 Apr 2020. 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 Netherlands. 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?
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?
Lung histology (time frame: December 2019). 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 6 Apr 2020.