100 Participants Needed

Circulating Tumor DNA for Cancer

Recruiting at 1 trial location
AC
RP
MR
Overseen ByMelissa Reimers, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect cancer recurrence early by using circulating tumor DNA (ctDNA). ctDNA consists of tiny fragments of a tumor's DNA found in the blood. By identifying these early signs, doctors aim to enhance treatment options and outcomes for patients with solid tumors. The trial is suitable for healthy individuals aged 18 and older. As a Phase 2 trial, it measures the effectiveness of this approach in an initial, smaller group, offering participants the opportunity to contribute to potentially groundbreaking cancer detection methods.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that circulating tumor DNA (ctDNA) is safe for earlier detection of disease recurrence?

Research has shown that using circulating tumor DNA (ctDNA) is generally safe for patients. Studies have examined ctDNA to assess treatment effectiveness in various cancers, such as lung, colorectal, and breast cancers. These studies have not identified any major safety issues with ctDNA. Instead, they focus on ctDNA's ability to detect cancer recurrence early.

Although ctDNA is a newer method, the absence of serious side effects in these studies suggests it is safe for patients. Additionally, ctDNA is being considered to enhance the monitoring and adjustment of cancer treatments, potentially leading to better patient outcomes.12345

Why are researchers excited about this trial?

Researchers are excited about using circulating tumor DNA (ctDNA) for early treatment response assessment of solid tumors because it offers a non-invasive way to monitor how well a treatment is working. Unlike traditional methods that require imaging or biopsies, ctDNA can be detected in a simple blood test, making it quicker and easier for both patients and doctors. This approach can potentially provide real-time feedback on treatment effectiveness, allowing for faster adjustments if a therapy isn’t working, ultimately leading to more personalized and timely cancer care.

What evidence suggests that circulating tumor DNA (ctDNA) is effective for earlier detection of disease recurrence?

Research has shown that a blood test for circulating tumor DNA (ctDNA) can effectively monitor the effectiveness of cancer treatments. One study found ctDNA in 91.2% of patients before surgery, a much higher rate than another common cancer marker. This suggests ctDNA might be more reliable for detecting cancer. Another study discovered that patients whose ctDNA was undetectable during treatment had an 88.4% chance of being cancer-free for two years. These findings indicate that ctDNA can serve as a strong early sign of treatment success and could aid in creating personalized care plans.26789

Who Is on the Research Team?

MR

Melissa Reimers, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are monitored for early treatment response using circulating tumor DNA (ctDNA) for solid tumors

6.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6.5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Circulating Tumor DNA (ctDNA)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

National Center for Advancing Translational Science (NCATS)

Collaborator

Trials
100
Recruited
32,100+

Roche Sequencing Solutions

Industry Sponsor

Trials
3
Recruited
23,100+

The V Foundation for Cancer Research

Collaborator

Trials
21
Recruited
1,300+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+

Radiological Society of North America

Collaborator

Trials
27
Recruited
1,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials
43
Recruited
6,600+

Skandalaris

Collaborator

Trials
1
Recruited
100+

Citations

Circulating tumor DNA to monitor treatment response in ...Because cfDNA is thought to be released largely as a result of cell death, it can provide information on treatment response, with recent data ...
Predictive Effectiveness of Circulating Tumor DNA in ...However, the predictive effectiveness of ctDNA remains uncertain because of variability in study designs, detection strategies, and statistical ...
Real-World Utilization and Performance of Circulating ...At 4 months after surgery, ctDNA was positive at 0.08% and the VAF gradually increased for 1 year despite no clinical symptoms and all normal ...
Clinical trial and real-world evidence of circulating tumor ...Results. Before surgery, the ctDNA detection rate was 91.2%, significantly higher than the carcinoembryonic antigen (CEA) elevation rate at 42.9%. At 2 ...
Dynamic circulating tumor DNA during chemoradiotherapy ...Longitudinal undetectable MRD was found in 20.1% patients. The 2-year cancer-specific progression-free survival of these patients was 88.4%, ...
Safety, efficacy, and on-treatment circulating tumor DNA ...We report safety, updated efficacy, and exploratory analyses of early ctDNA reduction with clinically active doses of RMC-6236 in patients with RAS mutant PDAC.
A Review of Circulating Tumor DNA (ctDNA) and the Liquid ...The detection methods for ctDNA require high sensitivity due to the low levels of tumor-specific DNA in the circulation. Tumor-specific somatic mutations and ...
Circulating Tumor DNA and Tissue Testing for ...This cohort study evaluates whether circulating tumor DNA and next-generation sequencing of tissue samples find the same actionable ...
Guidance for IndustryCirculating Tumor DNA Analysis Detects Minimal Residual Disease and Predicts Recurrence in. Patients with Stage II Colon Cancer, Sci Transl Med 8(346); 2016; ...
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