MRD Detection for Colorectal Cancer

(MRD Trial)

Not currently recruiting at 56 trial locations
ND
Overseen ByNSABP Department of Site and Study Management Department of Site and Study Management
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Exact Sciences Corporation
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 method to detect remaining cancer cells after surgery for colorectal cancer, which affects the colon or rectum. It focuses on patients who have undergone successful surgery to remove stage II or III colorectal cancer. The study monitors patients for up to seven years to determine if this method aids in detecting cancer recurrence. Suitable candidates have had their colorectal cancer completely removed in surgery within the last six months and have not yet started additional cancer treatment. Participants must provide blood samples and comply with study requirements. The trial uses MRD (minimal residual disease) detection to identify any remaining cancer cells.

As a Phase 2 trial, this research measures the effectiveness of the detection method in an initial, smaller group, offering participants the opportunity to contribute to potentially groundbreaking advancements in cancer monitoring.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about the Minimal Residual Disease (MRD) detection method in colorectal cancer because it offers a way to identify remaining cancer cells that might not be visible through traditional imaging. Most treatments for colorectal cancer, like surgery, chemotherapy, and radiation, focus on removing or killing visible tumors. However, MRD detection stands out by focusing on the microscopic level to catch cancer cells early, potentially preventing relapse. This innovative approach could lead to more personalized treatment plans and improve long-term outcomes for patients with stage II or III colorectal cancer.

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).
in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection")
histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-Surgical Monitoring

Participants are monitored for minimal residual disease using a circulating tumor DNA assay after complete surgical resection

3-5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MRD

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Stage ll or lllExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Exact Sciences Corporation

Lead Sponsor

Trials
36
Recruited
282,000+

NSABP Foundation Inc

Collaborator

Trials
89
Recruited
140,000+