Actively Recruiting
Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
Led by Washington University School of Medicine · Updated on 2026-02-20
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
R
Roche Sequencing Solutions
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of circulating tumor DNA (ctDNA) to detect early treatment responses and disease recurrence in patients with various solid tumors and healthy volunteers. The study aims to enhance cancer diagnosis, treatment, surveillance, and prognosis by integrating ctDNA into clinical practice, potentially guiding personalized medical decisions. This translational research could lead to future interventional trials focusing on early therapeutic escalation using ctDNA molecular residual disease detection. Participants include healthy donors and patients with cancers such as prostate, head and neck, esophageal, genitourinary, sarcoma, breast, colon, gastrointestinal, lung, skin, and melanoma. The study involves collecting blood and urine samples as often as every two months, up to 24 times, to generate reference data and compare patient data for molecular residual disease. Samples are also obtained from various tissue and plasma repositories and banking studies related to these cancers. During the study, participants will provide biological samples for analysis, which will be used to monitor outcomes including freedom from progression, event-free survival, disease-specific survival, overall survival, pathologic complete response rate, locoregional failure, and distant-metastasis-free survival. The study is expected to continue for approximately 6.5 years, with ongoing sample collection and outcome assessment under the oversight of Washington University School of Medicine.
CONDITIONS
Brief Title
Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible healthy donors must be at least 18 years old
You will not qualify if you...
- Healthy donors younger than 18 years old are not eligible to participate in the study or donate samples for research purposes
- Individuals with current cancer diagnoses are excluded from the healthy donor group (implied by focus on healthy donors in criteria but not explicitly stated in source; no explicit exclusion for cancer patients given source, so only age-based exclusion is listed here.)
- Not applicable (only age-based exclusion specified in source for healthy donors, no other exclusion criteria provided in source.)
- No additional exclusion criteria listed in the source data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm eligibility
Duration - Up to 6.5 years
Participants donate blood and/or urine samples periodically for research purposes.
Up to 24 sample donation visits occurring as often as every two months
Duration - Up to 6.5 years
Participants are observed for outcomes such as freedom from progression and survival over the course of the study.
Periodic assessments aligned with sample donations and study follow-up
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
M
Melissa Reimers, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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