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Updated: May 24, 2025

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

Alexia Exarchos1, Ariel B Bourla2, Maneet Kaur2

  • 1Genentech, Inc., South San Francisco, CA, USA.

Contemporary Clinical Trials Communications
|March 3, 2025
PubMed
Summary
This summary is machine-generated.

A new platform enabled rapid enrollment of cancer patients in community settings for a prospective clinico-genomic database. This approach facilitates real-world biomarker discovery and evidence generation outside major academic centers.

Keywords:
Circulating tumor DNAElectronic health recordsFeasibility studyLung neoplasmsProspective study

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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.