NCT04354064

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

Recruiting now Last updated 20 February 2026

What this trial tests

trial in Healthy Volunteer in 100 participants. Currently enrolling.

Timeline

29 May 2019

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Washington University School of Medicine
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	100
Start date	29 May 2019
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Conditions studied

• Healthy Volunteer — all drugs for Healthy Volunteer →
• Prostate Cancer — all drugs for Prostate Cancer →
• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Esophageal Cancer — all drugs for Esophageal Cancer →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Healthy Volunteer or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Liquid biopsy for therapy monitoring in early-stage non-small cell lung cancer.
   Nagasaka M, Uddin MH, Al-Hallak MN, Rahman S, et al · · 2021 · cited 91× · PMID 34074295 · DOI 10.1186/s12943-021-01371-1
2. A clinician's handbook for using ctDNA throughout the patient journey.
   Hasenleithner SO, Speicher MR. · · 2022 · cited 85× · PMID 35307037 · DOI 10.1186/s12943-022-01551-7
3. Cell-free DNA ultra-low-pass whole genome sequencing to distinguish malignant peripheral nerve sheath tumor (MPNST) from its benign precursor lesion: A cross-sectional study.
   Szymanski JJ, Sundby RT, Jones PA, Srihari D, et al · · 2021 · cited 62× · PMID 34464388 · DOI 10.1371/journal.pmed.1003734
4. Urine tumor DNA detection of minimal residual disease in muscle-invasive bladder cancer treated with curative-intent radical cystectomy: A cohort study.
   Chauhan PS, Chen K, Babbra RK, Feng W, et al · · 2021 · cited 58× · PMID 34464379 · DOI 10.1371/journal.pmed.1003732
5. Urine cell-free DNA multi-omics to detect MRD and predict survival in bladder cancer patients.
   Chauhan PS, Shiang A, Alahi I, Sundby RT, et al · · 2023 · cited 45× · PMID 36658307 · DOI 10.1038/s41698-022-00345-w
6. Early Detection of Malignant and Premalignant Peripheral Nerve Tumors Using Cell-Free DNA Fragmentomics.
   Sundby RT, Szymanski JJ, Pan AC, Jones PA, et al · · 2024 · cited 14× · PMID 39093127 · DOI 10.1158/1078-0432.ccr-24-0797
7. Circulating Human Papillomavirus DNA in Head and Neck Squamous Cell Carcinoma: Possible Applications and Future Directions.
   Adilbay D, Lele S, Pang J, Asarkar A, et al · · 2022 · cited 13× · PMID 36497430 · DOI 10.3390/cancers14235946
8. Liquid biopsies for colorectal cancer: a narrative review of ongoing clinical trials and the current use of this technology at a comprehensive cancer center.
   Broccard SP, Kasbi AA, Bagaria SP, Jones J, et al · · 2022 · cited 8× · PMID 35284120 · DOI 10.21037/jgo-21-470