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

January 2, 2024 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

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

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 Locations

  • United States
    • Missouri
      • Saint 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:
          • Aadel Chaudhuri, M.D., Ph.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.
        • Contact:
        • Principal Investigator:
          • Russell Pachynski, M.D.
        • Sub-Investigator:
          • Peter Harris, Ph.D.
        • Sub-Investigator:
          • Mackenzie Daly, M.D.
        • Sub-Investigator:
          • Ha Dang, Ph.D.
        • Sub-Investigator:
          • Paul Jones, B.A.
        • Sub-Investigator:
          • James Hsieh, M.D., Ph.D.
        • Sub-Investigator:
          • Zachary Smith, M.D.
        • Sub-Investigator:
          • Eric Kim, M.D.
        • Sub-Investigator:
          • Vivek Arora, M.D.
        • Sub-Investigator:
          • Matthew Spraker, M.D., Ph.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.

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

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
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

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

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

Washington University School of Medicine

Collaborators

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

  • Principal Investigator: Russell Pachynski, 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)

May 29, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Melanoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe