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Artificial Intelligence for Help Non-Small Cell Lung Cancer: Measure Cancer Biology and Treatment Response Via Imaging

NCT05254132 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-02-24

No results posted yet for this study

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 non-small cell lung cancer NSCLC (rATLAS) with a smaller biomarker minimally interventional study on patients with metastases who undergo liquid biopsy and imaging follow-up for 2 years (aRECIST). A total of 1120 patients will be screened to get 1000 participants enrolled in rATLAS, and a subset of 250 participants will be screened to then recruit 150 participants also for aRECIST. The study will end after one visit for participants in rATLAS while there is a 2-years follow-up period for participants in aRECIST. Participants will not receive any treatment specific for this study, but might receive standard of care therapy or investigational products in the framework of another clinical study following the baseline visit.

The objectives of optimizing AI based tools for the assessment of EGFR status (rATLAS) and automated Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1) (aRECIST) will be achieved using a trial design that combines a biomarker discovery study design (cross-sectional for rATLAS) with a reader study design (follow-up study in aRECIST). Medical treatments in the aRECIST cohort are not dictated by study protocol, rather determined by the clinicians in line with standard clinical practice.

Conditions

  • Non Small Cell Lung Cancer

Interventions

PROCEDURE

Liquid biopsy

Participants in the aRECIST group will undergo a blood draw for liquid biopsy analysis at baseline and follow up visits

Sponsors & Collaborators

  • University Hospital, Antwerp

    collaborator OTHER

  • OncoRadiomics

    lead INDUSTRY

Principal Investigators

  • Jan P Van Meerbeeck, MD · University Hospital, Antwerp

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2025-06-30
Completion
2025-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254132 on ClinicalTrials.gov