Breast Cancer, Colon Cancer, Esophageal Cancer, Gastrointestinal Cancer, Genitourinary Cancer, Head and Neck Cancer, Healthy Volunteer, Lung Cancer, Melanoma, Prostate Cancer, Sarcoma, Skin Cancer, Solid Tumor Cancer
Conditions
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.
Interventions
None listed
Sponsors
Washington University School of Medicine
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)
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Eligible healthy donors will be at least 18 years of age.
Exclusion criteria
* Healthy donors younger than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Disease-specific survival | Through completion of study (estimated to be 6.5 years) | -Defined as death from cancer |
| 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) | — |
| 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 |
| 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 |
Countries
United States
Contacts
CONTACTMelissa Reimers, M.D.
PRINCIPAL_INVESTIGATORMelissa Reimers, M.D.
Washington University School of Medicine
Outcome results
None listed