Collecting blood samples to improve colorectal cancer detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Lakeland Regional Cancer Center
  Lakeland, Florida, United States Recruiting
• Springfield Clinic
  Springfield, Illinois, United States Recruiting
• Mid Hudson Medical Research
  New Windsor, New York, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• Precision Recearch Institute
  Chula Vista, California, United States Completed
• Precision Research Institute
  San Diego, California, United States Completed

Study contacts

• Study coordinator: Antonio Jesus Merino Calvo
• Email: antonio.merino@universaldx.com
• Phone: (+34)674945571

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.