What is this study trying to find out about colorectal cancer?

This study is evaluating a blood-based biomarker panel to detect colorectal cancer and advanced adenomas. Researchers aim to optimize and assess the performance of circulating free DNA markers to help identify these conditions earlier. The research is sponsored by Universal Diagnostics and involves collecting blood samples from participants with suspected or diagnosed colorectal conditions.

Who may be eligible for this colorectal cancer clinical trial?

Adults aged 45 to 84 years who either have suspected advanced adenomas or new colorectal cancer diagnoses awaiting surgery, or those at average risk scheduled for screening colonoscopy may be eligible. The study includes all genders and excludes individuals with certain cancer histories or recent positive fecal tests. Please review eligibility criteria for more details.

Is there any cost to participate in this colorectal cancer clinical trial?

Study-related care, including the blood sample collection and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to attending study visits.

Actively Recruiting

Age: 45Years - 84Years

All Genders

Healthy Volunteers

ID04792684

Observational Study Collecting Blood Samples to Improve and Test a Blood Marker Panel for Detecting Colorectal Cancer and Advanced Adenomas in US Adults Aged 45 to 84

Led by Universal Diagnostics · Updated on 2025-11-10

1300

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a prospective multi-center observational study to optimize and evaluate a circulating free DNA cfDNA biomarker panel aimed at detecting colorectal cancer CRC and advanced adenomas. The study involves enrolling eligible subjects from the United States, including those suspected of having advanced adenomas or newly diagnosed with CRC scheduled for surgery, as well as average-risk individuals scheduled for routine colonoscopy. Participants will be assigned to one of two groups those with suspected advanced adenomas or new CRC diagnoses awaiting surgery, and those at average risk undergoing screening colonoscopy. Blood samples will be collected, with up to 40 ml drawn at the study visit, and clinical data will be gathered to assess the performance of the cfDNA biomarker panel. The study focuses on evaluating this diagnostic test through sample collection and marker testing. During the study, participants will provide blood samples and undergo clinical data collection. Researchers will monitor the samples collected within 12 months for plasma cfDNA marker testing. The study involves informed consent and ensures participants can comprehend and agree to participation. The total participation period may vary, but assessments focus on blood sampling and related testing to measure biomarker performance related to CRC and advanced adenomas.

CONDITIONS

Brief Title

Collection of Samples USOPTIVAL Study

Who Can Participate

Age: 45Years - 84Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Must be between 45 and 84 years old.
For Arm A: Must have a suspected advanced adenoma or be newly diagnosed with colorectal cancer not yet resected and scheduled for surgery.
For Arm B: Must be able and willing to undergo a standard screening colonoscopy within 60 days.
Able to understand, sign, and date the informed consent form.

You will not qualify if you...

For Arm A: Subjects with a curative biopsy during colonoscopy.
For Arm B: Subjects with a positive fecal immunochemical test (FIT) result in the past 6 months.
For Arm B: Subjects with a current cancer diagnosis.
Personal history of aerodigestive or digestive tract cancers.
Previous partial removal of colon for reasons other than colorectal cancer.
Known or personal history of high-risk colorectal cancer conditions, including inflammatory bowel disease, familial adenomatous polyposis, hereditary non-polyposis colorectal cancer syndrome, serrated polyposis syndrome, or certain family histories of colon cancer.
Significant disease that excludes participation per investigator.
Legal incapacity or limited mental capacity.
Medical or psychological conditions preventing study completion or consent.
Known history of infectious diseases transmissible by blood (e.g., Hepatitis, HIV).
Known pregnancy at enrollment or during study participation.

Research Team

Antonio Jesus Merino Calvo

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Observational Study Collecting Blood Samples to Improve and Test a Blood Marker Panel for Detecting Colorectal Cancer and Advanced Adenomas in US Adults Aged 45 to 84

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria