Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
Conditions
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, MelanomaSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Russell Pachynski, M.D.
- 314-286-2341
- [email protected]
Principal Investigator
- Russell Pachynski, M.D.
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
Study Plan
Healthy Donor Samples
* Donation of blood and/or urine samples as often as bi-monthly and as many as 24 times in totaln* 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 Repositoryn* Tissue, blood, and/or drain fluid samples from Head and Neck Banking studiesn* Tissue and/or blood samples from Esophageal Repositoryn* Tissue and/or blood samples from Genitourinary Repositoryn* Tissue and/or plasma from Sarcoma Tissue Bankn* Tissue and/or plasma from Breast Cancer Bankn* Tissue, plasma, and/or urine from GI Tissue and Blood Bankn* Tissue, blood, and/or urine from Solid Tumor Bankn* Tissue, blood, and/or urine from Lung Cancer Bankn* Tissue and/or blood from Skin Cancer Bankn* Tissue and/or blood from Pediatric Neurosurgery Tissue Bank
Outcome Measures
Primary Outcome Measures
Freedom from progression
Secondary Outcome Measures
Event-free survival
Disease-specific survival
Overall survival
Pathologic complete response rate
Locoregional failure
Distant-metastasis-free survival
Timeline
Last Updated
January 3, 2024Start Date
April 21, 2020Today
January 22, 2025Completion Date ( Estimated )
December 31, 2025
Sponsors of this trial
Lead Sponsor
Washington University School of MedicineCollaborating Sponsors
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)