Healthy VolunteerNCT04354064
Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
An observational study of Healthy Volunteer and Prostate Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Prostate Cancer, Head and Neck Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * This study will access data and specimens from patients who consented to specimen banks (approximately 3262 patients) There is a waiver of consent for this study regarding patient data banked under the tissue banks. * Healthy donors will be consented prior to sample acquisition (approximately 100 patients)
Who may be able to join
- Eligible healthy donors will be at least 18 years of age.
Who cannot join
- Healthy donors younger than 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Melissa Reimers, M.D., 314-362-7249, cbumb@wustl.edu
Melissa Reimers, M.D.
About this study
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, Sarcoma
- Medical subject headings
- Prostatic Neoplasms, Head and Neck Neoplasms, Esophageal Neoplasms, Urogenital Neoplasms, Sarcoma, Breast Neoplasms, Colonic Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from progression
-Defined as RECIST 1.1 based radiographic or clinical progression, with non-progressors censored at last radiographic follow-up
Measured: Through completion of study (estimated to be 6.5 years)
Secondary outcomes (6)
Event-free survival
-Defined as post-treatment ctDNA detection or RECIST 1.1 based radiographic progression
Measured: Through completion of study (estimated to be 6.5 years)
Disease-specific survival
-Defined as death from cancer
Measured: Through completion of study (estimated to be 6.5 years)
Overall survival
-Defined as death from any cause
Measured: Through completion of study (estimated to be 6.5 years)
Pathologic complete response rate
Measured: Through completion of study (estimated to be 6.5 years)
Locoregional failure
-Defined as clinical or radiographic progression within the localized tumor/treatment area or regional lymph nodes
Measured: Through completion of study (estimated to be 6.5 years)
Distant-metastasis-free survival
-Defined as clinical or radiographic progression outside the localized tumor/treatment area and regional lymph nodes
Measured: Through completion of study (estimated to be 6.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start29 May 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Sequencing Solutions, The Foundation for Barnes-Jewish Hospital, National Center for Advancing Translational Sciences (NCATS), Radiological Society of North America, Skandalaris, The V Foundation for Cancer Research, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Melissa Reimers, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354064
- Sponsor's protocol ID
- 201903142
- Status last verified
- Feb 2026
- First submitted
- 16 Apr 2020
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification will be available for sharing with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
- ClinicalTrials.gov ID
- NCT04354064
- Acronym / sponsor ID
- 201903142
- Conditions
- Healthy Volunteer, Prostate Cancer, Head and Neck Cancer, Esophageal Cancer, Genitourinary Cancer, Sarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Roche Sequencing Solutions, The Foundation for Barnes-Jewish Hospital, National Center for Advancing Translational Sciences (NCATS), Radiological Society of North America, Skandalaris, The V Foundation for Cancer Research, National Institute of General Medical Sciences (NIGMS)
- Study start
- 29 May 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * This study will access data and specimens from patients who consented to specimen banks (approximately 3262 patients) There is a waiver of consent for this study regarding patient data banked under the tissue banks. * Healthy donors will be consented prior to sample acquisition (approximately 100 patients)
Key inclusion criteria (1 listed)
- Eligible healthy donors will be at least 18 years of age.
Key exclusion criteria (1 listed)
- Healthy donors younger than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Freedom from progression
Time frame: Through completion of study (estimated to be 6.5 years)
-Defined as RECIST 1.1 based radiographic or clinical progression, with non-progressors censored at last radiographic follow-up
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification will be available for sharing with other researchers.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Reimers, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer and Prostate Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Reimers, M.D. (314-362-7249, cbumb@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from progression (time frame: Through completion of study (estimated to be 6.5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.