Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Healthy Donor Samples
- Conditions
- Healthy Volunteer
- Sponsor
- Washington University School of Medicine
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Freedom from progression
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible healthy donors will be at least 18 years of age.
Exclusion Criteria
- •Healthy donors younger than 18 years of age
Arms & Interventions
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
Outcomes
Primary Outcomes
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
- Event-free survival(Through completion of study (estimated to be 6.5 years))
- Locoregional failure(Through completion of study (estimated to be 6.5 years))
- Overall survival(Through completion of study (estimated to be 6.5 years))
- 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))
- Distant-metastasis-free survival(Through completion of study (estimated to be 6.5 years))