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Recruiting NCT04354064

Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors

— Observational Healthy Volunteer Prostate Cancer Head and Neck Cancer Esophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Healthy Volunteer, Prostate Cancer, Head and Neck Cancer, Esophageal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Earlier detection of disease recurrence will enable greater treatment options and has strong potential to improve patient outcomes. This project is translational and has the potential to lead to future translational research opportunities, including interventional trials in which therapeutic escalation is offered at the early circulating tumor DNA (ctDNA) molecular residual disease (MRD) detection timepoint. Ultimately, the integration of ctDNA into the clinical workflow has the potential to enhance cancer diagnosis, treatment, surveillance, and prognosis, and guide clinical decision-making in this era of personalized precision medicine.

Primary outcome measures

  • Freedom from progression [Time frame: Through completion of study (estimated to be 6.5 years)]
Secondary outcome measures (6)
  • Event-free survival [Time frame: Through completion of study (estimated to be 6.5 years)]
  • Disease-specific survival [Time frame: Through completion of study (estimated to be 6.5 years)]
  • Overall survival [Time frame: Through completion of study (estimated to be 6.5 years)]
  • Pathologic complete response rate [Time frame: Through completion of study (estimated to be 6.5 years)]
  • Locoregional failure [Time frame: Through completion of study (estimated to be 6.5 years)]
  • Distant-metastasis-free survival [Time frame: Through completion of study (estimated to be 6.5 years)]

Eligibility criteria

Inclusion criteria

  • Eligible healthy donors will be at least 18 years of age.

Exclusion criteria

  • Healthy donors younger than 18 years of age

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT04354064 · 201903142

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗