Signal-C for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Kara Mattox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Universal Diagnostics

Disqualifiers: Colorectal cancer, Malignancy, IBD, others

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

Compensation: Varies

Number of Visits: Unknown

12000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively the Signal-C™ blood test can detect colorectal cancer and advanced precancerous lesions. It targets individuals aged 45 to 84 who have been informed by a healthcare provider that they have an average risk of developing colorectal cancer. Participants should plan to undergo a regular screening colonoscopy. The trial seeks individuals without recent colorectal screenings or a history of colorectal issues. As a Phase 2 trial, this research focuses on assessing the test's performance in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in early cancer detection.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if 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 Signal-C™ test is safe for detecting colorectal cancer?

Research shows that Signal-C™, a blood test for detecting colorectal cancer, is generally easy for people to handle. The test itself has no known side effects. It examines free DNA in the blood to assess cancer risk.

In past studies, Signal-C™ proved very accurate. It correctly identified 93% of colorectal cancer cases and was 92% accurate in ruling out cancer when absent. However, a small chance of false negatives exists, where the test might indicate no cancer when it is present.

Overall, this test is considered safe, with no direct safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to evaluate the Signal-C test, which could transform how we screen for colorectal cancer. Unlike traditional colonoscopies that require invasive procedures, this test is non-invasive, making it potentially more comfortable and accessible for patients. The innovation lies in its ability to detect colorectal cancer risk through new biomarkers, which could lead to earlier and more accurate detection. If successful, this test might offer a simpler, more patient-friendly alternative to current screening methods.

What evidence suggests that Signal-C™ is effective for detecting colorectal cancer?

Research has shown that Signal-C™, a blood test, effectively detects colorectal cancer. It accurately identifies 93% of cases, meaning it usually detects cancer correctly. With a specificity of 92%, the test rarely gives false alarms. This makes Signal-C a promising tool for early detection of colorectal cancer, which can lead to better treatment outcomes. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

You are capable and eager to sign a consent form.

You must be between 45 and 84 years old at the time of consent.

You are eligible for the standard procedure of colorectal screening via colonoscopy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Participants undergo a standard-of-care screening colonoscopy and Signal-C test evaluation

1 year

Follow-up

Participants are monitored for safety and effectiveness after the observational phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Signal-C™

How Is the Trial Designed?

Group I: Average risk Experimental Treatment 1 Intervention

Patients aged between 45 and 84, who are at average risk of developing colorectal cancer, and are scheduled for a standard-of-care screening colonoscopy.

Who Is Running the Clinical Trial?

Universal Diagnostics

Lead Sponsor

Trials

3

Recruited

16,400+

Premier Research Group plc

Collaborator

Premier Research Group plc

Industry Sponsor

Trials

65

Recruited

74,200+

John Ratliff

Premier Research Group plc

Chief Executive Officer since 2024

MBA

Dr. Milena Kanova-Petrova

Premier Research Group plc

Chief Medical Officer since 2024

MD

Yanuvia, LLC

Collaborator

Trials

1

Recruited

15,000+

Science 37

Industry Sponsor

Trials

3

Recruited

15,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06059963

Study Details | NCT06059963 | A Prospective, Multi-center ... To evaluate the performance characteristics of Signal-C™ a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions (APL) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9974876/

Emerging Tests for Non-Invasive Colorectal Cancer Screening A recent survey of the MarketScan Commercial and Medicare Supplemental databases found 70% adherence with colon cancer screening, which is below the 80% ...

3. investors.guardanthealth.com investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Health-ECLIPSE-Study-Data-Demonstrating-Efficacy-of-Shield-Blood-based-Test-for-Colorectal-Cancer-Screening-to-be-Published-in-The-New-England-Journal-of-Medicine/default.aspx

Guardant Health ECLIPSE Study Data Demonstrating ... Study shows blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90%; Results pave the way for ...

4. universaldx.com universaldx.com/multicancer-platform

Signal C Universal DX first blood test, Signal-C®, accurately detects colorectal cancer with sensitivity of 93% and specificity of 92%.

5. biospace.com biospace.com/new-data-from-universal-dx-demonstrates-effective-detection-of-early-stage-colorectal-cancer-using-combination-of-methylation-fragmentation-and-machine-learning

New Data from Universal DX Demonstrates Effective ... Its first single-draw blood test, Signal-C, detects colorectal cancer with high sensitivity and specificity, with extraordinary accuracy for ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230009B.pdf

summary of safety and effectiveness data (ssed) o One out of 1000 patients testing negative will be falsely reassured that they are negative for CRC, given the negative predictive value of 99.9%. • A false ...

7. cghjournal.org cghjournal.org/article/S1542-3565(25)00320-9/fulltext

AGA Clinical Practice Update on Current Role of Blood ... The sensitivity of current blood tests for APLs and stage 1 CRC is low. It remains to be seen if overall population adherence with CRC screening ...

8. myadlm.org myadlm.org/cln/articles/2025/mayjune/can-a-blood-test-help-close-the-colorectal-cancer-screening-gap

Can a blood test help close the colorectal cancer screening ... The clinical validation study of 7,861 people found a sensitivity of 83.1% for detection of colorectal cancers, including an 87.5% sensitivity ...