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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05819905
Other study ID # REGAL
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date January 1, 2024

Study information

Verified date April 2023
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date January 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically proven NSCLCC - pre treatment 18F FDG PET/CT - available molecular biology and histology results Exclusion Criteria: - non available PET/CT images

Study Design


Intervention

Diagnostic Test:
PET/CT
Pre treatment staging 18F-FDG PET/CT

Locations

Country Name City State
France CHU Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month
Primary 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. 1 month
Secondary 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. 1 month
Secondary 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. 1 month
Secondary 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. 1 month
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