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

Recruiting

• Conditions: Healthy Volunteer; Esophageal Cancer; Colon Cancer; Prostate Cancer; Head and Neck Cancer; Solid Tumor Cancer; Genitourinary Cancer; Sarcoma; Breast Cancer; Gastrointestinal Cancer

• Registration Number: NCT04354064
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-05-29
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• Healthy donors younger than 18 years of age

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from progression	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

Name	Time	Method
Event-free survival	Through completion of study (estimated to be 6.5 years)	-Defined as post-treatment ctDNA detection or RECIST 1.1 based radiographic progression
Locoregional failure	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
Overall survival	Through completion of study (estimated to be 6.5 years)	-Defined as death from any cause
Pathologic complete response rate	Through completion of study (estimated to be 6.5 years)
Disease-specific survival	Through completion of study (estimated to be 6.5 years)	-Defined as death from cancer
Distant-metastasis-free survival	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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States