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The INFINITY study protocol: a retrospective cohort study on decision making and clinical impact of biomarker-driven

Uwe M Martens1,2, Jan Schröder3, Fee Bengsch4

  • 1Clinic for Hematology, Oncology and Palliative Care, SLK Kliniken Heilbronn, Heilbronn, Germany.

BMC Cancer
|June 13, 2023
PubMed
Abstract

Insights

The INFINITY registry collects real-world data on precision oncology treatments for advanced cancers in Germany. This study addresses the need for systematic outcome data in routine clinical practice for targeted therapies.

Area of Science:

  • Oncology
  • Genomics
  • Clinical Trials

Background:

  • Precision oncology uses targeted therapies based on molecular alterations, increasingly as a last resort for advanced cancers.
  • Systematic collection and analysis of patient outcomes for these off-label precision oncology treatments are lacking.
  • The INFINITY registry was established to address this knowledge gap by collecting real-world evidence.

Purpose of the Study:

  • To provide evidence on the current biomarker landscape guiding treatment decisions in routine clinical care.
  • To gain insights into the effectiveness of precision oncology approaches.
  • To analyze specific drug class/alteration matches used outside approved indications.

Main Methods:

  • Retrospective, non-interventional cohort study at ~100 German sites.
  • Inclusion of 500 patients with advanced solid tumors or hematologic malignancies receiving non-standard targeted therapy.
  • Systematic collection of patient/disease characteristics, molecular testing, decision-making, treatment, and outcomes.

Main Results:

  • N/A - Study ongoing, results to be published.

Conclusions:

  • The INFINITY registry will elucidate the biomarker landscape and treatment patterns in German precision oncology.
  • It will offer crucial insights into the real-world effectiveness of targeted therapies in advanced cancers.
  • Findings will inform clinical decision-making and guide future precision medicine strategies.
Keywords:
Actionable alterationNon-interventional studyNon-standard targeted therapyPrecision oncologyReal-world data

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