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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354064
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : March 17, 2023
Sponsor:
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)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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.

Condition or disease
Healthy Volunteer Prostate Cancer Head and Neck Cancer Esophageal Cancer Genitourinary Cancer Sarcoma Breast Cancer Colon Cancer Gastrointestinal Cancer Solid Tumor Cancer Lung Cancer Skin Cancer Melanoma

Study Design
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Study Type : Observational
Estimated Enrollment : 3362 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Disease-specific survival [ Time Frame: Through completion of study (estimated to be 6.5 years) ]
    -Defined as death from cancer

  3. Overall survival [ Time Frame: Through completion of study (estimated to be 6.5 years) ]
    -Defined as death from any cause

  4. Pathologic complete response rate [ Time Frame: Through completion of study (estimated to be 6.5 years) ]
  5. 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

  6. 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


Biospecimen Retention:   Samples With DNA
  • Blood and/or urine from healthy volunteers under this study
  • The remaining samples (tissue, blood, drain fluid, urine, plasma) will be collected under various repository and banking studies at Washington University School of Medicine

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Healthy donors younger than 18 years of age
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354064


Contacts
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Contact: Aadel Chaudhuri, M.D., Ph.D. 314-273-2931 aadel@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Aadel Chaudhuri, M.D., Ph.D.    314-273-2931    aadel@wustl.edu   
Principal Investigator: Aadel Chaudhuri, M.D., Ph.D.         
Sub-Investigator: Peter Harris, Ph.D.         
Sub-Investigator: Re-I Chin, M.D.         
Sub-Investigator: Hiram Gay, M.D.         
Sub-Investigator: Mackenzie Daly, M.D.         
Sub-Investigator: Wade Thorstad, M.D.         
Sub-Investigator: Jose Zevallos, M.D., MPH         
Sub-Investigator: Sidharth Puram, M.D., Ph.D.         
Sub-Investigator: Varun Puri, M.D.         
Sub-Investigator: Christopher Maher, Ph.D.         
Sub-Investigator: Ha Dang, Ph.D.         
Sub-Investigator: Russell Pachynski, M.D., Ph.D.         
Sub-Investigator: Paul Jones, B.A.         
Sub-Investigator: Benjamin Tan, M.D.         
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: Brian Van Tine, M.D., Ph.D.         
Sub-Investigator: Angela Hirbe, M.D., Ph.D.         
Sub-Investigator: Matthew Spraker, M.D., Ph.D.         
Sub-Investigator: Cynthia Ma, M.D., Ph.D.         
Sub-Investigator: Imran Zoberi, M.D.         
Sub-Investigator: Ryan Fields, M.D.         
Sub-Investigator: Koushik Das, M.D.         
Sub-Investigator: Ricardo Ramirez, M.D.         
Sub-Investigator: David Chen, M.D., Ph.D.         
Sub-Investigator: Nicholas Semenkovich, M.D., Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
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)
Investigators
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Principal Investigator: Aadel Chaudhuri, M.D., Ph.D. Washington University School of Medicine
More Information
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Additional Information:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04354064    
Other Study ID Numbers: 201903142
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification will be available for sharing with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Urogenital Neoplasms
Neoplasms
Neoplasms by Site
 Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases