ctDNA-Informed Management for Rectal Cancer
(ULTIMATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates how well the Signatera Genome ultra-sensitive ctDNA blood test can guide treatment for individuals with early-stage rectal cancer. The goal is to determine if the test can predict who might avoid surgery after initial treatments like chemotherapy and radiation. Participants will either use the blood test to decide on next steps or follow the usual surgery route after treatment. The trial seeks individuals diagnosed with rectal cancer who have already completed specific chemotherapy and radiation treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for 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 team or your doctor.
What prior data suggests that the Signatera Genome ultra-sensitive ctDNA blood test is safe for use in early-stage rectal cancer management?
Previous studies have used the Signatera Genome ultra-sensitive ctDNA blood test to monitor colorectal cancer. This blood test helps predict the potential return of cancer and has been used to check for cancer after surgery.
The test is non-invasive, avoiding surgery or complicated procedures, making it generally safe and easy to manage. Evidence shows no major side effects or risks from the blood test itself.
However, as this is a phase 2 study, researchers continue to gather more information on its effectiveness and overall safety. So far, the Signatera test has been used successfully in other studies for similar purposes without significant safety concerns.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how a cutting-edge blood test, the Signatera ultra-sensitive ctDNA test, might change the way rectal cancer is managed. Unlike traditional approaches that often rely on surgery and chemotherapy, this trial investigates a "Watch and Wait" surveillance strategy, using the blood test to detect tiny fragments of cancer DNA in the bloodstream. This method could potentially help doctors decide if surgery can be safely postponed or even avoided, reducing the patient's exposure to invasive procedures. By focusing on personalized cancer monitoring, this trial aims to offer a more tailored, less invasive approach to managing rectal cancer.
What evidence suggests that this trial's treatments could be effective for rectal cancer?
Research has shown that the Signatera Genome blood test can detect cancer recurrence earlier than traditional methods. In studies with colorectal cancer patients, it has effectively identified small amounts of residual cancer after treatment. One study demonstrated that this test helped identify potential relapses in stage II colon cancer patients, enabling early intervention. By tracking tiny pieces of tumor DNA in the blood, the test offers a more accurate way to monitor cancer. In this trial, participants in the "ctDNA informed management arm" will undergo Watch and Wait surveillance using this test, which may aid in managing early-stage rectal cancer by providing timely information on treatment effectiveness.12367
Who Is on the Research Team?
Ankit Sarin, MD
Principal Investigator
University of California, Davis
Are You a Good Fit for This Trial?
This trial is for individuals with early-stage rectal cancer. Participants must be eligible to undergo total neoadjuvant therapy (TNT). Specific inclusion and exclusion criteria details are not provided, but typically these would involve health status, prior treatments, and other medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Total Neoadjuvant Therapy (TNT)
Participants receive total neoadjuvant therapy as part of the standard of care
ctDNA Informed Management
Participants are assigned to either ctDNA informed management (Watchful Waiting) or post TNT SOC surgery based on ctDNA assay results
Follow-up
Participants are monitored for ctDNA positivity and disease-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Signatera Genome ultra-sensitive ctDNA blood test
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
National Cancer Institute (NCI)
Collaborator