Clinical trial NCT04354064: Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
Official title: Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Roche Sequencing Solutions
name: The Foundation for Barnes-Jewish Hospital
name: National Center for Advancing Translational Sciences (NCATS)
name: Radiological Society of North America
name: Skandalaris
name: The V Foundation for Cancer Research
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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)

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.


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

Primary outcomes:
measure: Freedom from progression
timeFrame: Through completion of study (estimated to be 6.5 years)
Secondary outcomes:
measure: Event-free survival
timeFrame: Through completion of study (estimated to be 6.5 years)
measure: Disease-specific survival
timeFrame: Through completion of study (estimated to be 6.5 years)
measure: Overall survival
timeFrame: Through completion of study (estimated to be 6.5 years)
measure: Pathologic complete response rate
timeFrame: Through completion of study (estimated to be 6.5 years)
measure: Locoregional failure
timeFrame: Through completion of study (estimated to be 6.5 years)
measure: Distant-metastasis-free survival
timeFrame: Through completion of study (estimated to be 6.5 years)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Melissa Reimers, M.D.
role: PRINCIPAL_INVESTIGATOR
References: