Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform

Area of Science:

• Oncology
• Genomics
• Biomarker Discovery

Background:

• Clinico-genomic datasets are crucial for identifying predictive and prognostic cancer biomarkers.
• Historically, biomarker research infrastructure has been limited to large academic centers.
• A technology-enabled platform was developed to enable biomarker research at community-based sites.

Purpose of the Study:

• To evaluate the feasibility of a pragmatic, technology-enabled platform for creating a prospective clinico-genomic database.
• To support biomarker research in community oncology settings.
• To link real-world clinical data with tumor sequencing data.

Main Methods:

• Adults with stage IV or recurrent metastatic non-small cell lung cancer or extensive-stage small-cell lung cancer were enrolled at 23 US sites.
• Electronic health record (EHR) data were centrally processed and normalized.
• Serial blood samples were collected for circulating tumor DNA (ctDNA) genomic profiling at multiple timepoints.

Main Results:

• 944 patients were enrolled between December 2019 and May 2021, representing approximately 25% of eligible patients.
• High rates of ctDNA sample collection were achieved at baseline (87%), during treatment (67%), and at disease progression (47%).
• 35% of participants provided samples at all three timepoints.

Conclusions:

• A community-based oncology patient cohort was rapidly enrolled, establishing a real-world clinico-genomic dataset.
• This pragmatic study platform demonstrates potential for generating evidence through prospective real-world data collection.
• The platform facilitates biomarker research in diverse community settings.