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Related Experiment Video

Updated: Aug 7, 2025

Detection and Monitoring of Tumor Associated Circulating DNA in Patient Biofluids
06:53

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Published on: June 8, 2019

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Clinical Circulating Tumor DNA Testing for Precision Oncology.

Hyunji Kim1, Kyoung Un Park1

  • 1Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.

Cancer Research and Treatment
|March 14, 2023
PubMed
Summary

Circulating tumor DNA (ctDNA) is tumor-derived DNA found in blood. Understanding ctDNA test characteristics and validation is crucial for reliable clinical application in cancer care.

Keywords:
Circulating tumor DNAClinical utilityClinical validationPrecision oncology

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Area of Science:

  • Oncology
  • Molecular Biology
  • Genetics

Background:

  • Circulating tumor DNA (ctDNA) originates from tumor cells and is present in patient plasma.
  • Plasma ctDNA levels range from 5-10 ng/mL, mixed with normal DNA and DNA from clonal hematopoiesis.
  • ctDNA has a short half-life, clearing from circulation rapidly (16 minutes to 2.5 hours).

Purpose of the Study:

  • To elucidate the characteristics of circulating tumor DNA (ctDNA) tests.
  • To review the validation and approval status of various ctDNA testing methodologies.
  • To guide the careful consideration of ctDNA test selection for clinical use.

Main Methods:

  • Review of ctDNA characteristics, including origin, concentration, and half-life.
  • Analysis of the requirements for standardized clinical validation of ctDNA assays.
  • Assessment of the current approval status for different ctDNA tests.

Main Results:

  • ctDNA tests vary in their validation and approval status.
  • Reliable ctDNA detection necessitates adherence to standardized clinical validation guidelines.
  • The clinical utility of ctDNA testing depends on specific test characteristics and needs.

Conclusions:

  • Standardized validation is essential for reliable ctDNA test results.
  • Clinical decisions regarding ctDNA testing require careful evaluation of individual test performance.
  • Further standardization and validation are needed to optimize the clinical application of ctDNA.