Non Small Cell Lung CancerNCT05819905
Radiomics for prEdiction of lunG cAncer biologY
An observational study of Non Small Cell Lung Cancer and PET/CT, run by Poitiers University Hospital at 1 site in France.
Trial summary
Therapeutic progress for subgroups of Non Small Cell Lung Cancer can largely be attributed to the accumulation of molecular knowledge and the development of new drugs that specifically target molecular abnormalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, PET/CT, PD-L1
- What is being tested?
- PET/CT
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Jan 2024
- 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: Histologically proven NSCLC with molecular biology analysis and initial staging PET/CT
Who may be able to join
- Histologically proven NSCLCC
- pre treatment 18F FDG PET/CT
- available molecular biology and histology results
Who cannot join
- non available PET/CT images
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Lung Cancer Characteristics Using PET/CT Radiomics
Therapeutic progress for subgroups of Non Small Cell Lung Cancer can largely be attributed to the accumulation of molecular knowledge and the development of new drugs that specifically target molecular abnormalities. An understanding of the immune landscape of tumors, including immune-evasion strategies, has also led to breakthrough therapeutic advances.These new options require prior treatment tumoral sampling to identify patients who have neoplasms with specific genomic aberrations or favorable immune environment. Medical imaging and radiomic approach may provides surrogate markers non invasively.The objective of the present retrospective study is to build and validate a predictive model of common molecular alterations and PD-L1 expression in NSCLC using pre treatment PET/CT derived radiomics.
- Being tested
- PET/CT
- 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.
PET/CTDiagnostic test
Pre treatment staging 18F-FDG PET/CT
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of PDL1 expression
Evaluation of the performances of PET/CT derived radiomics to predict PDL1 expression >1% (PDL1 : Programmed death-ligand 1 as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.
Measured: 1 month
prediction of EGFR genomic alteration
Evaluation of the performances of PET/CT derived radiomics to predict the presence of EGFR mutation (EGFR: epidermal growth factor receptor, presence /or not of EGFR alteration as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.
Measured: 1 month
Secondary outcomes (3)
Prediction of KRAS alteration
Evaluation of the performances of PET/CT derived radiomics to predict the presence of KRAS mutation (KRAS : Kirsten rat sarcoma viral oncogene : presence/or not of KRAS alteration as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.
Measured: 1 month
Prediction of BRAF mutation
Evaluation of the performances of PET/CT derived radiomics to predict the presence of BRAF mutation (BRAF : raf murine sarcoma viral oncogene homolog B, presence/or not of BRAF mutation as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.
Measured: 1 month
Prediction of ALK/ROS translocation
Evaluation of the performances of PET/CT derived radiomics to predict the presence of ALK/ROS translocation (ALK : anaplastic lymphoma receptor tyrosine kinase, ROS : c-ROS protooncogene 1; presence /or not of ALK and ROS alteration as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819905
- Sponsor's protocol ID
- REGAL
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Lung Cancer Characteristics Using PET/CT Radiomics
- ClinicalTrials.gov ID
- NCT05819905
- Acronym / sponsor ID
- REGAL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 19 Apr 2023 (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.
Therapeutic progress for subgroups of Non Small Cell Lung Cancer can largely be attributed to the accumulation of molecular knowledge and the development of new drugs that specifically target molecular abnormalities. An understanding of the immune landscape of tumors, including immune-evasion strategies, has also led to breakthrough therapeutic advances.These new options require prior treatment tumoral sampling to identify patients who have neoplasms with specific genomic aberrations or favorable immune environment. Medical imaging and radiomic approach may provides surrogate markers non invasively.The objective of the present retrospective study is to build and validate a predictive model of common molecular alterations and PD-L1 expression in NSCLC using pre treatment PET/CT derived radiomics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically proven NSCLC with molecular biology analysis and initial staging PET/CT
Key inclusion criteria (3 listed)
- Histologically proven NSCLCC
- pre treatment 18F FDG PET/CT
- available molecular biology and histology results
Key exclusion criteria (1 listed)
- non available PET/CT images
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 |
|---|---|---|
| PET/CTPre treatment staging 18F-FDG PET/CT | Diagnostic test | – |
Primary outcome
prediction of PDL1 expression
Time frame: 1 month
Evaluation of the performances of PET/CT derived radiomics to predict PDL1 expression >1% (PDL1 : Programmed death-ligand 1 as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.
prediction of EGFR genomic alteration
Time frame: 1 month
Evaluation of the performances of PET/CT derived radiomics to predict the presence of EGFR mutation (EGFR: epidermal growth factor receptor, presence /or not of EGFR alteration as previously determined on routine tumoral biopsy): area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity.
3 secondary outcomes
Prediction of KRAS alteration
Time frame: 1 month
Prediction of BRAF mutation
Time frame: 1 month
Prediction of ALK/ROS translocation
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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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 Non Small Cell Lung Cancer and PET/CT, run by Poitiers University Hospital at 1 site in France.
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 3 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 19 Apr 2023. 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 France. 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?
prediction of PDL1 expression (time frame: 1 month). 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 19 Apr 2023.