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

February 17, 2026 updated by: Washington University School of Medicine
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Melissa Reimers, M.D.
  • Phone Number: 314-362-7249
  • Email: cbumb@wustl.edu

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Sub-Investigator:
          • Benjamin Tan, M.D.
        • Sub-Investigator:
          • Ryan Fields, M.D.
        • Sub-Investigator:
          • Sidharth Puram, M.D., Ph.D.
        • Sub-Investigator:
          • Brian Van Tine, M.D., Ph.D.
        • Sub-Investigator:
          • Re-I Chin, M.D.
        • Sub-Investigator:
          • Varun Puri, M.D.
        • Sub-Investigator:
          • Wade Thorstad, M.D.
        • Sub-Investigator:
          • Hiram Gay, M.D.
        • Sub-Investigator:
          • Koushik Das, M.D.
        • Sub-Investigator:
          • Angela Hirbe, M.D., Ph.D.
        • Sub-Investigator:
          • Imran Zoberi, M.D.
        • Sub-Investigator:
          • Jose Zevallos, M.D., MPH
        • Sub-Investigator:
          • Christopher Maher, Ph.D.
        • Sub-Investigator:
          • Peter Harris, Ph.D.
        • Sub-Investigator:
          • Ha Dang, Ph.D.
        • Sub-Investigator:
          • Paul Jones, B.A.
        • Sub-Investigator:
          • Zachary Smith, M.D.
        • Sub-Investigator:
          • Eric Kim, M.D.
        • Sub-Investigator:
          • Vivek Arora, M.D.
        • Sub-Investigator:
          • Cynthia Ma, M.D., Ph.D.
        • Sub-Investigator:
          • Ricardo Ramirez, M.D.
        • Sub-Investigator:
          • David Chen, M.D., Ph.D.
        • Sub-Investigator:
          • Nicholas Semenkovich, M.D., Ph.D.
        • Principal Investigator:
          • Melissa Reimers, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Healthy donors younger than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Through completion of study (estimated to be 6.5 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: Through completion of study (estimated to be 6.5 years)
-Defined as post-treatment ctDNA detection or RECIST 1.1 based radiographic progression
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)
-Defined as death from cancer
Through completion of study (estimated to be 6.5 years)
Overall survival
Time Frame: Through completion of study (estimated to be 6.5 years)
-Defined as death from any cause
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)
Through completion of study (estimated to be 6.5 years)
Locoregional failure
Time Frame: Through completion of study (estimated to be 6.5 years)
-Defined as clinical or radiographic progression within the localized tumor/treatment area or regional lymph nodes
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)
-Defined as clinical or radiographic progression outside the localized tumor/treatment area and regional lymph nodes
Through completion of study (estimated to be 6.5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Foundation for Barnes-Jewish Hospital
National Institute of General Medical Sciences (NIGMS)
Roche Sequencing Solutions
National Center for Advancing Translational Sciences (NCATS)
Radiological Society of North America
The V Foundation for Cancer Research
Skandalaris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melissa Reimers, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201903142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification will be available for sharing with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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