White paperFor pharma & CROs

Circulating tumour DNA as a biomarker in clinical trials.

A practical guide to using ctDNA across an oncology trial: detecting molecular residual disease, enriching cohorts with high-risk patients, and monitoring response, and how each of those can cut the size, cost and timeline of your study.

What you will take away

8x
Smaller enrolment in a worked stage III colorectal example, by enriching for ctDNA-positive patients.
75%
Lower per-patient cost in the same example, after treatment and ctDNA screening.
<0.01%
VAF sensitivity for tumour-informed assays, versus above 0.5% for tumour-naive panels.
10-20x
Sample-size reduction indicated by registered ctDNA-enrichment trials (MEDOCC-CrEATE, DARE).

What is inside

  1. 01 ctDNA as a biomarker: what it is and why it matters in trials
  2. 02 Tumour-informed versus tumour-naive detection, compared
  3. 03 The CHIP false-positive problem, and how to avoid it
  4. 04 Using ctDNA across the trial: MRD, recurrence and response
  5. 05 MRD for patient enrichment, with a worked cost model
  6. 06 Lessons from large adjuvant trials (PALLAS, APHINITY)
  7. 07 Response monitoring and atypical immunotherapy patterns
  8. 08 References

Who it is for

  • Clinical development and biomarker leads designing oncology trials
  • CRO scientific and operations teams scoping ctDNA endpoints
  • Translational and medical affairs teams building the evidence case
Talk to us

Want this applied to your trial?

A real human, in CET/CEST time zone, who has run samples like yours.

inbox@simsendiagnostics.com →