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

NCT04354064 | Recruiting

• 1 other identifier: 201903142
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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; Melanoma

Outcome Measures

Primary Outcomes (1)

• Freedom from progression

  -Defined as RECIST 1.1 based radiographic or clinical progression, with non-progressors censored at last radiographic follow-up

  Through completion of study (estimated to be 6.5 years)

Secondary Outcomes (6)

• Event-free survival

  Through completion of study (estimated to be 6.5 years)

• Disease-specific survival

  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)

• Locoregional failure

  Through completion of study (estimated to be 6.5 years)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* This study will access data and specimens from patients who consented to specimen banks (approximately 3262 patients) There is a waiver of consent for this study regarding patient data banked under the tissue banks. * Healthy donors will be consented prior to sample acquisition (approximately 100 patients)

You may qualify if:

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

You may not qualify if:

• Healthy donors younger than 18 years of age

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator
• Radiological Society of North America: collaborator
• Skandalaris: collaborator
• The V Foundation for Cancer Research: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator
• Roche Sequencing Solutions: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Biospecimen

Retention: SAMPLES WITH DNA

* Blood and/or urine from healthy volunteers under this study * The remaining samples (tissue, blood, drain fluid, urine, plasma) will be collected under various repository and banking studies at Washington University School of Medicine

MeSH Terms

Conditions

Prostatic Neoplasms; Head and Neck Neoplasms; Esophageal Neoplasms; Urogenital Neoplasms; Sarcoma; Breast Neoplasms; Colonic Neoplasms; Gastrointestinal Neoplasms; Lung Neoplasms; Skin Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas

Study Officials

• Melissa Reimers, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Reimers, M.D.

CONTACT

314-362-7249; cbumb@wustl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: May 29, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)