Collecting blood samples to improve colorectal cancer detection
Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance ("USOPTIVAL")
This study is trying to see if blood samples can help improve the detection of colorectal cancer and advanced adenomas in people who are at risk or have just been diagnosed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1300 (estimated) |
| Ages | 45 Years to 84 Years |
| Sex | All |
| Sponsor | Universal Diagnostics Industry-sponsored |
| Locations | 16 sites (Chula Vista, California and 15 other locations) |
| Trial ID | NCT04792684 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect blood samples and clinical data from participants suspected of having advanced adenomas or newly diagnosed with colorectal cancer. It will also include individuals at average risk undergoing routine colonoscopy. The goal is to optimize a circulating free DNA (cfDNA) marker panel for better detection of colorectal cancer and advanced adenomas. Participants will provide up to 40 ml of blood during the study visit after giving informed consent.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45-84 with suspected advanced adenomas or newly diagnosed colorectal cancer scheduled for surgery, as well as those at average risk undergoing routine colonoscopy.
Not a fit: Patients with a current diagnosis of cancer or those who have had a curative biopsy during colonoscopy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of colorectal cancer and advanced adenomas, potentially saving lives.
How similar studies have performed: Other studies have shown promise in using cfDNA markers for cancer detection, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chula Vista, California and 15 other locations
- Precision Recearch Institute — Chula Vista, California, United States (Completed)
- Precision Research Institute — San Diego, California, United States (Completed)
- Medical Associates Research Group — San Diego, California, United States (Completed)
- Clinical Research of California — Walnut Creek, California, United States (Completed)
- Center for Gastrointestinal Disorders — Hollywood, Florida, United States (Completed)
- Lakeland Regional Cancer Center — Lakeland, Florida, United States (Recruiting)
- Springfield Clinic — Springfield, Illinois, United States (Recruiting)
- Ochsner Clinic — New Orleans, Louisiana, United States (Completed)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Completed)
- Mid Hudson Medical Research — New Windsor, New York, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Completed)
- Frontier Clinical Research — Uniontown, Pennsylvania, United States (Completed)
- Clinical Trials Network — Union City, Tennessee, United States (Completed)
- Vilo Research Group — Houston, Texas, United States (Completed)
- Gastroenterology Consultants of SW Virginia — Raonoke, Virginia, United States (Completed)
Study contacts
- Study coordinator: Antonio Jesus Merino Calvo
- Email: antonio.merino@universaldx.com
- Phone: (+34)674945571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.