Collection of Samples USOPTIVAL Study

Launched by UNIVERSAL DIAGNOSTICS · Mar 8, 2021

Keywords

ClinConnect Summary

The USOPTIVAL Study is a clinical trial designed to better understand how to detect colorectal cancer (CRC) and advanced adenomas (a type of abnormal growth in the colon) using a specific blood test that looks for genetic material from cancer cells. This is an observational study, which means it aims to gather information from participants rather than testing a new treatment. The trial is currently recruiting individuals aged 45 to 84 who either have a suspected advanced adenoma or have been newly diagnosed with colorectal cancer and are scheduled for surgery. Participants will either be those needing a surgery or those who are set to undergo a standard screening colonoscopy.

To be eligible, potential participants must be in the specified age range and able to provide informed consent, meaning they understand and agree to participate in the study. Some individuals may not qualify, especially if they have had certain types of cancer in the past, have specific medical conditions, or are currently pregnant. Participants in this study can expect to provide blood and other samples, which will be used to help researchers optimize the test for better detection of colorectal issues. Your involvement may contribute to important advancements in how we detect these conditions in the future.

Gender

ALL

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.