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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Healthy donors younger than 18 years of age

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04354064
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Washington University School of Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Melissa Reimers, M.D.
Principal Investigator Affiliation Washington University School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Study Website: View Trial Website
Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington University School of Medicine, St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Washington University School of Medicine

St Louis 4407066, Missouri 4398678, 63110

Site Contact

Melissa Reimers, M.D.

[email protected]

314-362-7249

Stay Informed & Connected