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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Healthy donors younger than 18 years of age

Trial 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)

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Healthy Donor Samples
Group B: Samples from Repository and Banking Studies

Trial outcomes

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

Time frame
Through completion of study (estimated to be 6.5 years)

Secondary outcomes

1

Event-free survival

-Defined as post-treatment ctDNA detection or RECIST 1.1 based radiographic progression

Time frame
Through completion of study (estimated to be 6.5 years)
2

Disease-specific survival

-Defined as death from cancer

Time frame
Through completion of study (estimated to be 6.5 years)
3

Overall survival

-Defined as death from any cause

Time frame
Through completion of study (estimated to be 6.5 years)
4

Pathologic complete response rate

Time frame
Through completion of study (estimated to be 6.5 years)

Other outcomes

Sponsors and contacts

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Washington University School of Medicine

Lead sponsor

Roche Sequencing Solutions

Collaborator

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