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

The Washington University

Status: Enrolling

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

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT04354064

201903142

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Healthy donors younger than 18 years of age

Trial design

100 participants in 2 patient groups

Healthy Donor Samples

Description:

* 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

Description:

* 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