Status:
UNKNOWN
Artificial Intelligence for Help Non-Small Cell Lung Cancer: Measure Cancer Biology and Treatment Response Via Imaging
Lead Sponsor:
OncoRadiomics
Collaborating Sponsors:
University Hospital, Antwerp
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
SALMON is a prospective, multi-center, multi-country, biomarker validation study that synergizes an extensive non-interventional biomarker discovery study on diagnostic images and tissue biopsies of n...
Detailed Description
Lung cancer is the leading cause of cancer-related death worldwide, accounting for an estimated 2.1 million deaths in 2018. About 80%-85% of lung cancers are NSCLC. The main subtypes of NSCLC are aden...
Eligibility Criteria
Inclusion
- Participant must be aged at least 18 years
- Willing and able to comply with clinic visits and study-related procedures.
- Willing and able to provide signed informed consent.
- Participant must be at first diagnosis of NSCLC and have the largest diameter of the primary tumor equal or greater than 2 cm.
- Participant must be treatment naïve (includes radiotherapy).
- Participant must have received a CT scan for the diagnosis of NSCLC according to "Imaging Protocol" document (Appendix 1).
- Participant with confirmed availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or ≥25 unstained slides (at least 10 unstained slides). Participant without adequate archival tumor specimens cannot be included
- Additional inclusion criteria specific to aRECIST cohort:
- Participant must be diagnosed with NSCLC Stage IV.
- Participant must have a life expectancy ≥ 3 months.
- Participant must have at least one lesion that is suitable for accurate repeated assessment (according to RECIST criteria).
- Participant must be able to comply with standard of care visits for imaging purposes to follow-up on treatment response.
- Participant must need to agree to undergo a liquid biopsy at baseline and at follow-up visits.
- Participant must undergo either chemotherapy or immunotherapy after baseline visit, according to SoC.
Exclusion
- Pregnant or breast-feeding participants (to avoid radiation exposure)
- Participant is either an employee of Radiomics or the investigational center or an immediate relative of an employee of Radiomics or the investigational center.
- Participant with total body CT scan already performed at a different site with acquisition parameters different from those reported in the Imaging Protocol
- Additional inclusion criteria specific to aRECIST cohort:
- • Participant who previously underwent or are planned for curable cancer surgery (lobectomy, wedge resection, pneumonectomy) or ablative radiotherapy on metastases.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05254132
Start Date
July 1 2022
End Date
June 30 2025
Last Update
February 24 2022
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