| NCT ID | NCT04792684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universal Diagnostics |
| Condition | Colorectal Cancer (CRC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2020-12-30 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,300 participants in total. It began in 2020-12-30 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A prospective multi-center observational study. The study will enroll eligible subjects from the United States to optimize the biomarker panel and evaluate the performance of a cfDNA marker panel selected by the Sponsor for CRC and advanced adenoma detection.
Eligibility Criteria
Inclusion Criteria: Arm A: 1. Must be 45-84 years of age. 2. Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery. 3. Able to comprehend, sign, and date the written informed consent document. Arm B: 1. Must be 45-84 years of age. 2. Able and willing to undergo a standard-of-care screening colonoscopy within 60 days. 3. Able to comprehend, sign, and date the written informed consent document. Exclusion Criteria: Arm A Only: 1\. Subject with curative biopsy during colonoscopy. Arm B Only: 1. Subjects with positive FIT Test results in the 6 months preceding enrollment. 2. Subject has a current diagnosis of cancer. Arms A \& B: 1. Subject has a personal history of aerodigestive or digestive tract cancers. 2. Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer. 3. Has a known diagnosis or personal history of any of the following high-risk indications for colorectal cancer: 1. Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease. 2. Familial adenomatous polyposis ("FAP", including attenuated FAP). 3. Hereditary non-polyposis colorectal cancer syndrome ("HNPCC" or "Lynch Syndrome"). 4. Serrated polyposis syndrome 5. 2 first-degree relatives (e.g., parents, siblings, and offspring) who have been diagnosed with colon cancer. 6. One first-degree relative with CRC diagnosed before the age of 60. 4. A significant disease which, in the Investigator's opinion, would exclude the subject from the study. 5. Legal incapacity or limited mental capacity. 6. Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent. 7. The patient has a known or documented previous or current medical history of infectious diseases that can be transmitted through blood (E.g. Hepatitis, HIV, etc.), including patients that have been treated, are currently being treated, or have not been treated for that conditions. 8. The patient is known to be pregnant when recruited or during her participation in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04792684 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 84 Years, studying Colorectal Cancer (CRC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04792684 currently recruiting?
Yes, NCT04792684 is actively recruiting participants. Contact the research team at antonio.merino@universaldx.com for enrollment information.
Where is the NCT04792684 trial being conducted?
This trial is being conducted at Chula Vista, United States, San Diego, United States, San Diego, United States, Walnut Creek, United States and 11 additional locations.
Who is sponsoring the NCT04792684 clinical trial?
NCT04792684 is sponsored by Universal Diagnostics. The trial plans to enroll 1,300 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.