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Collection of Samples USOPTIVAL Study

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")

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 84 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects samples to improve and test a panel of DNA markers for finding colorectal cancer (cancer of the colon or rectum) and advanced adenomas (growths that may turn into cancer). It is for U.S. adults ages 45–84 who are scheduled for surgery for these conditions or plan to have a routine screening colonoscopy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: You must be 45–84 years old.
  • Both groups: You must understand, sign, and date a written consent form.
  • Group A: You must have a suspected advanced adenoma or newly diagnosed colorectal cancer that has not yet been removed, and be scheduled for surgery.
  • Group B: You must be able and willing to have a routine screening colonoscopy within 60 days. This test uses a small camera to look inside the colon.

Who can't join

  • Group A only: A biopsy during colonoscopy fully removed the growth or cancer.
  • Group B only: You had a positive FIT stool test for blood in the past 6 months, or you currently have cancer.
  • Both groups: You have had cancer in the breathing, swallowing, or digestive passages, or had part of your colon removed for a reason other than colorectal cancer.
  • Both groups: You have inflammatory bowel disease, including ulcerative colitis or Crohn’s disease; FAP, including attenuated FAP; Lynch syndrome; or serrated polyposis syndrome. These conditions cause bowel swelling or raise the risk of colon growths or cancer.
  • Both groups: Two parents, siblings, or children have had colon cancer, or one had colorectal cancer before age 60.
  • Both groups: The study doctor thinks a serious illness makes you unable to join, or legal, mental, medical, or emotional limits keep you from giving consent or finishing the study.
  • Both groups: You have or have had an infection that can spread through blood, such as hepatitis or HIV, whether treated or not.
  • Both groups: You are known to be pregnant when you join or during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (16)

CA

FL

IL

LA

MA

NY

PA

TN

TX

VA