Recruiting

ctDNA

Sponsor:

Washington University School of Medicine

Code:

NCT04354064

Conditions

Healthy Volunteer

Prostate Cancer

Head and Neck Cancer

Esophageal Cancer

Genitourinary Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Healthy Volunteer

Prostate Cancer

Head and Neck Cancer

Esophageal Cancer

Genitourinary Cancer

Study ID

NCT04354064

Start date

May 29, 2019

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Healthy donors younger than 18 years of age

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Donor Samples

  • Donation of blood and/or urine samples as often as bi-monthly and as many as 24 times in total
  • These samples will be used to generate reference data to compare patient data to and/or to correct stereotypic noise.

Samples from Repository and Banking Studies

  • Healthy prostate and/or blood and/or urine samples from Genitourinary Repository
  • Tissue, blood, and/or drain fluid samples from Head and Neck Banking studies
  • Tissue and/or blood samples from Esophageal Repository
  • Tissue and/or blood samples from Genitourinary Repository
  • Tissue and/or plasma from Sarcoma Tissue Bank
  • Tissue and/or plasma from Breast Cancer Bank
  • Tissue, plasma, and/or urine from GI Tissue and Blood Bank
  • Tissue, blood, and/or urine from Solid Tumor Bank
  • Tissue, blood, and/or urine from Lung Cancer Bank
  • Tissue and/or blood from Skin Cancer Bank
  • Tissue and/or blood from Pediatric Neurosurgery Tissue Bank

Primary outcome measure

  • Freedom from progression [ Time Frame: Through completion of study (estimated to be 6.5 years) ]

Central Contacts and Locations

Central contacts

Melissa Reimers, M.D.

314-362-7249cbumb@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Melissa Reimers, M.D.

314-362-7249cbumb@wustl.edu

Principal Investigator:

Melissa Reimers, M.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-02-20.