Minimal Residual Disease Testing for Colorectal Cancer

Recruiting at 12 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Unresected metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new blood test, the Haystack assay, detects the return of colorectal cancer after surgery more effectively than the current test, Signatera®. It focuses on patients with stage II to IV colorectal cancer that can be surgically removed. The trial will compare these two tests to identify which one detects cancer recurrence earlier, potentially improving treatment success. This trial suits those with stage II-IV colorectal cancer who have had or will undergo surgery to remove it and are open to regular blood testing for a few years. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could enhance cancer detection and treatment strategies.

Will I have to stop taking my current medications?

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.

What prior data suggests that this MRD testing is safe for colorectal cancer patients?

Research has shown that the Haystack and Signatera tests are being compared for their effectiveness in detecting small amounts of remaining cancer in colorectal cancer patients. The Haystack test excels at identifying tiny traces of tumor DNA in the blood after surgery. This capability could facilitate early detection of cancer recurrence, which is crucial for improving patient outcomes.

Both the Haystack and Signatera tests require only a simple blood draw, making them generally safe and easy to manage. No major side effects have been reported from the blood collection process, which resembles a routine blood test. The primary difference between the tests lies in their ability to detect cancer recurrence. Early results suggest that the Haystack test may outperform the Signatera test in this regard, although both are considered reliable for monitoring.

As these tests are non-invasive and involve standard blood draws, they pose minimal risk to participants. The primary focus remains on their cancer detection capabilities, not on safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Minimal Residual Disease (MRD) testing for colorectal cancer because it offers a more precise way to monitor the disease than traditional methods. Unlike standard imaging and blood tests, MRD testing uses advanced techniques like Haystack MRD and Signatera to detect tiny amounts of cancer DNA in the blood. This method has the potential to catch cancer recurrence much earlier, allowing for timely interventions. By providing this level of sensitivity, MRD testing helps tailor treatment plans more effectively, potentially improving long-term outcomes for patients.

What evidence suggests that minimal residual disease testing is effective for early detection of colorectal cancer recurrence?

Research has shown that testing for minimal residual disease (MRD) can help detect cancer returning after surgery. Studies indicate that patients who test positive for MRD after chemotherapy are 17.5 times more likely to experience cancer recurrence compared to those who test negative. In this trial, participants will undergo MRD testing using both the Haystack and Signatera tests. The Haystack test, a new method, might detect cancer recurrence more effectively than the current Signatera test used for colorectal cancer. Early evidence suggests that the Haystack test could be more effective at spotting cancer's return, potentially improving treatment success. This makes MRD testing a crucial part of monitoring cancer after surgery. ^{1 4 6 7 8}

Who Is on the Research Team?

Marwan G Fakih

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with stage II-IV colorectal cancer that can be surgically removed. It's designed to test if a new blood test, the Haystack assay, is better at detecting early signs of cancer coming back after surgery compared to the current Signatera assay.

Inclusion Criteria

I have enough tissue samples for testing.

I am scheduled for or have had surgery to remove my cancer.

Documented written informed consent of the participant

Exclusion Criteria

I am unable to understand or sign the consent form.

My cancer has spread and cannot be removed with surgery.

Inability to safely provide sequential blood samples

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Surgery Testing

Patients undergo archival tissue and blood sample collection and Haystack MRD and Signatera ctDNA/cfDNA testing prior to standard of care surgical resection

1 week

1 visit (in-person)

Post-Surgery Monitoring

Blood sample collection and Haystack MRD and Signatera ctDNA/cfDNA testing 3-10 weeks after surgery, every 3 months for 2 years post-surgery, and then every 6 months for years 3-5 post-surgery in the absence of disease progression

5 years

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Minimal Residual Disease Testing

Trial Overview The study compares two types of blood tests: the Haystack assay and the Signatera® assay. These tests look for tiny traces of cancer (minimal residual disease) that could indicate a risk of recurrence in patients who've had surgery for colorectal cancer.

How Is the Trial Designed?

Group I: Screening (Haystack MRD, Signatera) Experimental Treatment 3 Interventions

Patients undergo archival tissue and blood sample collection and Haystack MRD and Signatera ctDNA/cfDNA testing prior SOC surgical resection. Patients then undergo blood sample collection and Haystack MRD and Signatera ctDNA/cfDNA testing 3-10 weeks after surgery, every 3 months for 2 years post-surgery, and then every 6 months for years 3-5 post-surgery in the absence of disease progression.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e15710

Minimal residual disease (MRD) test utilization in the first 6 ... Outcomes included the number MRD tests, time between tests, and use of systemic cancer therapies in the 180- day follow-up after index date.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12186373/

Circulating tumor DNA for MRD detection in colorectal cancer After adjuvant chemotherapy, MRD-positive patients have a 17.5-fold increased risk of recurrence compared to those who test negative. Similarly, ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)04981-0/fulltext

Minimal residual disease in colorectal cancer. Tumor ... Minimal residual disease (MRD), defined as clinically undetectable tumor remnants post-treatment, reflects incomplete resection or ineffective ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07125729

Study Details | NCT07125729 | Minimal Residual Disease ... This clinical trial compares minimal residual disease (MRD) testing with the Haystack blood test (assay) to the Signatera® assay for the ...

5. nature.com nature.com/articles/s41591-024-03254-6

ctDNA-based molecular residual disease and survival in ... Remarkably, 36-month DFS for MRD-positive and MRD-negative patients were 16.7% (95% CI: 12.1–21.9%) versus 83.5% (95% CI: 81.2–85.6%). The ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-05428

Minimal Residual Disease Testing for the Early Detection ... This clinical trial compares minimal residual disease (MRD) testing with the Haystack blood test (assay) to the Signatera® assay for the early detection of ...

7. haystackmrd.com haystackmrd.com/publications-and-presentations/

Publications and presentations Haystack MRD's highly sensitive ctDNA test can be used to detect the presence of minimal residual disease (MRD) in early-stage cancer patients after curative- ...

8. trialx.com trialx.com/clinical-trials/listings/307160/minimal-residual-disease-testing-for-the-early-detection-of-cancer-recurrence-in-resectable-stage-ii-iv-colorectal-cancer-patients/

Minimal Residual Disease Testing for ... This clinical trial compares minimal residual disease (MRD) testing with the Haystack blood test (assay) to the Signatera® assay for the early ...