Colorectal CancerNCT06059963
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
An observational study of Colorectal Cancer and Advanced Adenocarcinoma, run by Universal Diagnostics at 1 site in United States.
Trial summary
To evaluate the performance characteristics of Signal-C™ a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions (APL) in an average risk screening population for 45 and over. Read more about this study
- Who is it for?
- Ages 45 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Advanced Adenocarcinoma
- What is being tested?
- Signal-C™
- Type of treatment
- Medical device
- How many people
- 12,000 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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. Approximately 12,000 subjects will need to be enrolled. Enrollment is event-driven and will be stopped when the required number of CRC cases have been confirmed with a final histopathological diagnosis.
Who may be able to join
- Subjects aged 45-84 years at time of consent
- Intended to undergo a standard-of-care screening colonoscopy
- Considered by a physician or healthcare provider as being of 'average risk' for CRC
- Willing to consent to blood draw prior to bowel preparatory procedures or undergoing colonoscopy ideally within 90 days of the date of the investigational blood draw.
- Willing to consent to follow-up for one year as per protocol
- Able and willing to sign informed consent
Who cannot join
- Undergoing colonoscopy for investigation of CRC risk symptoms
- Has undergone colonoscopy within preceding 9 years
- Positive FIT/FOBT result within the previous 12 months (+/- 3 months)
- Has completed Cologuard or Epi proColon testing within the previous 3 years.
- Has undergone a CT colonography in the prior 4 years.
- History of colorectal cancer.
Show all 14Show fewer
- History of any malignancy within prior 5 years.
- Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).
- Positive family history of colorectal cancer, defined as having a first- degree relative (parent, sibling, or child) with CRC diagnosed at age <60 years or with more than one first-degree relative diagnosed with CRC at any age.
- Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC [HNPCC], or Familial Adenomatous Polyposis [FAP]).
- Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
- Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
- Known pregnancy at informed consent, blood sample collection, and during study participation.
- Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Gastroenterology Consultants of SW Virginia
Raonoke, Virginia, 24014
Vishal Bhagat
About this study
To evaluate the performance characteristics of Signal-C™ a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions (APL) in an average risk screening population for 45 and over.
- Conditions
- Colorectal Cancer, Advanced Adenocarcinoma
- Being tested
- Signal-C™
- Keywords
- Advanced Precancerous Lesions
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signal-C™Device
Signal-C™ is a qualitative next generation sequencing-based in vitro diagnostic assay that uses targeted hybridization-based capture next-generation sequencing together with bioinformatics and machine learning algorithm for detection and combination of methylation and fragmentation associated DNA marker regions. Signal-C™ utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected via venipuncture in Streck Cell-Free DNA Blood Collection Tubes (BCTs).
| Study group | Role | What they receive |
|---|---|---|
| Average risk | 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. Receives: Device: Signal-C™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
The primary objective of this study is to determine the sensitivity for CRC and specificity for advanced neoplasia (AN). Advance Neoplasia (AN) is defined as a final diagnosis of CRC or Advanced Precancerous Lesion (APL).
Measured: 1 year
Secondary outcomes (1)
Secondary Objective
To determine sensitivity for advanced precancerous lesions (APL). To determine NPV and PPV for colorectal cancer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start18 Jan 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universal Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059963
- Sponsor's protocol ID
- CRC-US-003
- Status last verified
- Nov 2025
- First submitted
- 20 Sep 2023
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
- ClinicalTrials.gov ID
- NCT06059963
- Acronym / sponsor ID
- CRC-US-003
- Conditions
- Colorectal Cancer, Advanced Adenocarcinoma
- Keywords
- Advanced Precancerous Lesions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Universal DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the performance characteristics of Signal-C™ a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions (APL) in an average risk screening population for 45 and over.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Average risk | – | Device: Signal-C™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 may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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. Approximately 12,000 subjects will need to be enrolled. Enrollment is event-driven and will be stopped when the required number of CRC cases have been confirmed with a final histopathological diagnosis.
Key inclusion criteria (6 listed)
- Subjects aged 45-84 years at time of consent
- Intended to undergo a standard-of-care screening colonoscopy
- Considered by a physician or healthcare provider as being of 'average risk' for CRC
- Willing to consent to blood draw prior to bowel preparatory procedures or undergoing colonoscopy ideally within 90 days of the date of the investigational blood draw.
- Willing to consent to follow-up for one year as per protocol
Key exclusion criteria (14 listed)
- Undergoing colonoscopy for investigation of CRC risk symptoms
- Has undergone colonoscopy within preceding 9 years
- Positive FIT/FOBT result within the previous 12 months (+/- 3 months)
- Has completed Cologuard or Epi proColon testing within the previous 3 years.
- Has undergone a CT colonography in the prior 4 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Signal-C™Signal-C™ is a qualitative next generation sequencing-based in vitro diagnostic assay that uses targeted hybridization-based capture next-generation sequencing together with bioinformatics and machine learning algorithm for detection and combination of methylation and fragmentation associated DNA marker regions. Signal-C™ utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected via venipuncture in Streck Cell-Free DNA Blood Collection Tubes (BCTs). | Device | Average risk |
Primary outcome
Primary Objective
Time frame: 1 year
The primary objective of this study is to determine the sensitivity for CRC and specificity for advanced neoplasia (AN). Advance Neoplasia (AN) is defined as a final diagnosis of CRC or Advanced Precancerous Lesion (APL).
1 secondary outcome
Secondary Objective
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Advanced Adenocarcinoma, run by Universal Diagnostics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kara Mattox ((+1)3392085320, kara.mattox@universaldx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.