UPCC 04221 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)

Investigating Plasma DNA Markers for Colorectal Cancer Detection

UPCC 04221 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)
Enrolling By Invitation
45 years - 84 years
All
Phase N/A
1300 participants needed
1 Location

Brief description of study

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.

Detailed description of study

This study is designed to prospectively collect blood samples and clinical data from subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC scheduled for resection surgery, as well as subjects who are at average-risk of colorectal cancer and who are scheduled for routine colonoscopy examination.

Subjects interested in participation and who meet inclusion criteria and provide written informed consent will be enrolled in the study. By accepting participation in the study, subjects will consent to provide up to 40 ml of blood at the study visit.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Colorectal Cancer (CRC), Advanced Adenomas (AA)
  • Age: 45 years - 84 years
  • Gender: All

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.

This study investigates the use of circulating free-DNA (cfDNA) markers in blood to improve detection of colorectal cancer (CRC) and advanced adenomas. The purpose of this study is to collect blood samples and clinical data from participants in order to optimize a biomarker panel for better detection of these conditions.

Participants in this study will provide up to 40 ml of blood during a study visit. This is a multi-center observational study, meaning that researchers will observe participants as they receive routine care without altering their treatment. Participants will include those newly diagnosed with CRC or suspected of having advanced adenomas, as well as individuals at average risk of colorectal cancer undergoing routine colonoscopy.

  • Who can participate: Participants must be between 45 and 84 years old. Those eligible for Arm A should have a suspected advanced adenoma or a CRC diagnosis scheduled for surgery. Arm B participants should be scheduled for a routine colonoscopy. All participants must be able to provide informed consent. Participants must not have a history of certain cancers or conditions that could affect study outcomes.
  • Study details: Participants will be required to provide a blood sample during a study visit. The study is observational, meaning no treatment changes will occur. Participants will follow their standard medical care as usual.
Updated on 28 Jul 2026. Study ID: 20-1358
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Abramson Cancer Center Navigator