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Recruiting

NCT Number: NCT04354064

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

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.

Recruiting

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Key information

Conditions

Healthy Volunteer Breast Cancer Breast Diseases Breast Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Genitourinary Cancer Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Prostate Cancer Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Solid Tumor Cancer Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Angela Hirbe, M.D., Ph.D.

SUB_INVESTIGATOR

Benjamin Tan, M.D.

SUB_INVESTIGATOR

Brian Van Tine, M.D., Ph.D.

SUB_INVESTIGATOR

Christopher Maher, Ph.D.

SUB_INVESTIGATOR

Cynthia Ma, M.D., Ph.D.

SUB_INVESTIGATOR

David Chen, M.D., Ph.D.

SUB_INVESTIGATOR

Eric Kim, M.D.

SUB_INVESTIGATOR

Ha Dang, Ph.D.

SUB_INVESTIGATOR

Hiram Gay, M.D.

SUB_INVESTIGATOR

Imran Zoberi, M.D.

SUB_INVESTIGATOR

Jose Zevallos, M.D., MPH

SUB_INVESTIGATOR

Koushik Das, M.D.

SUB_INVESTIGATOR

Melissa Reimers, M.D.

CONTACT

[email protected]

314-362-7249

Melissa Reimers, M.D.

PRINCIPAL_INVESTIGATOR

Nicholas Semenkovich, M.D., Ph.D.

SUB_INVESTIGATOR

Paul Jones, B.A.

SUB_INVESTIGATOR

Peter Harris, Ph.D.

SUB_INVESTIGATOR

Re-I Chin, M.D.

SUB_INVESTIGATOR

Ricardo Ramirez, M.D.

SUB_INVESTIGATOR

Ryan Fields, M.D.

SUB_INVESTIGATOR

Sidharth Puram, M.D., Ph.D.

SUB_INVESTIGATOR

Varun Puri, M.D.

SUB_INVESTIGATOR

Vivek Arora, M.D.

SUB_INVESTIGATOR

Wade Thorstad, M.D.

SUB_INVESTIGATOR

Zachary Smith, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Healthy donors younger than 18 years of age

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Reimers, M.D.

CONTACT

[email protected]

314-362-7249

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of General Medical Sciences (NIGMS)
  • Radiological Society of North America
  • Roche Sequencing Solutions
  • Skandalaris
  • The Foundation for Barnes-Jewish Hospital
  • The V Foundation for Cancer Research

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2020
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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