Colorectal Cancer (CRC)NCT04792684
Collection of Samples USOPTIVAL Study
An observational study of Colorectal Cancer (CRC) and Advanced Adenomas (AA), run by Universal Diagnostics at 16 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (CRC), Advanced Adenomas (AA)
- What is being tested?
- Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
- How many people
- 1,300 participants
- Where
- 16 sitesUnited States
- Study dates
- 30 Dec 2020to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two cohorts of patients aged between 45 and 84, who have a suspected advanced adenoma or have been newly diagnosed with CRC, still not resected and scheduled for surgery, and patients who are at average risk of developing colorectal cancer, scheduled for a standard-of-care screening colonoscopy. Subjects will be considered enrolled after understanding and signing the ICF and a determination is made by the Investigator that the subject is eligible to participate according to the inclusion/exclusion criteria. Enrollment will be stopped when a sufficient number of confirmed cases of colorectal cancer, advanced adenomas, and matching control subjects have been enrolled. Under the current assumptions, 1,200 subjects will need to be enrolled.
Who may be able to join
- Arm A:
- Must be 45-84 years of age.
- Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery.
- Able to comprehend, sign, and date the written informed consent document.
- Arm B:
- Must be 45-84 years of age.
- Able and willing to undergo a standard-of-care screening colonoscopy within 60 days.
- Able to comprehend, sign, and date the written informed consent document.
Who cannot join
- Arm A Only:
- 1. Subject with curative biopsy during colonoscopy.
- Arm B Only:
- Subjects with positive FIT Test results in the 6 months preceding enrollment.
- Subject has a current diagnosis of cancer.
- Arms A \& B:
Show all 20Show fewer
- Subject has a personal history of aerodigestive or digestive tract cancers.
- Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer.
- Has a known diagnosis or personal history of any of the following high-risk indications for colorectal cancer:
- Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
- Familial adenomatous polyposis ("FAP", including attenuated FAP).
- Hereditary non-polyposis colorectal cancer syndrome ("HNPCC" or "Lynch Syndrome").
- Serrated polyposis syndrome
- 2 first-degree relatives (e.g., parents, siblings, and offspring) who have been diagnosed with colon cancer.
- One first-degree relative with CRC diagnosed before the age of 60.
- A significant disease which, in the Investigator's opinion, would exclude the subject from the study.
- Legal incapacity or limited mental capacity.
- Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent.
- 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.
- The patient is known to be pregnant when recruited or during her participation in the study.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 4 recruiting
- Completed
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Completed
Precision Recearch Institute
Chula Vista, California, 91910
- Completed
Center for Gastrointestinal Disorders
Hollywood, Florida, 33021
- Completed
Vilo Research Group
Houston, Texas, 77017
- Recruiting
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Manuel Molina
- Completed
Ochsner Clinic
New Orleans, Louisiana, 70121
- Recruiting
Mid Hudson Medical Research
New Windsor, New York, 12553
Sashi Makam
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Bryson Katona
- Completed
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
- Completed
Gastroenterology Consultants of SW Virginia
Raonoke, Virginia, 24014
- Completed
Precision Research Institute
San Diego, California, 92114
- Completed
Medical Associates Research Group
San Diego, California, 92123
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Peter Hofmann
- Completed
Clinical Trials Network
Union City, Tennessee, 38261
- Completed
Frontier Clinical Research
Uniontown, Pennsylvania, 15401
- Completed
Clinical Research of California
Walnut Creek, California, 94598
About this study
Official title: 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")
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer (CRC), Advanced Adenomas (AA)
- Being tested
- Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimization of Plasma Circulating Free-DNA (cfDNA) Marker PanelDiagnostic test
Evaluate the performance of a preliminary panel of biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Arm A. | Subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC still not resected and scheduled for surgery Receives: Diagnostic Test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel | |
| Arm B | Subjects at average-risk for CRC and scheduled for CRC screening colonoscopy Receives: Diagnostic Test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing
Samples Collected for Testing
Measured: Within 12 months of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start30 Dec 2020
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universal Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792684
- Sponsor's protocol ID
- CRC-US-001
- Status last verified
- Nov 2025
- First submitted
- 8 Mar 2021
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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")
- ClinicalTrials.gov ID
- NCT04792684
- Acronym / sponsor ID
- CRC-US-001
- Conditions
- Colorectal Cancer (CRC), Advanced Adenomas (AA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Universal DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A. | – | Diagnostic Test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker PanelSubjects that have a suspected advanced adenoma or have been newly diagnosed with CRC still not resected and scheduled for surgery |
| Arm B | – | Diagnostic Test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker PanelSubjects at average-risk for CRC and scheduled for CRC screening colonoscopy |
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two cohorts of patients aged between 45 and 84, who have a suspected advanced adenoma or have been newly diagnosed with CRC, still not resected and scheduled for surgery, and patients who are at average risk of developing colorectal cancer, scheduled for a standard-of-care screening colonoscopy. Subjects will be considered enrolled after understanding and signing the ICF and a determination is made by the Investigator that the subject is eligible to participate according to the inclusion/exclusion criteria. Enrollment will be stopped when a sufficient number of confirmed cases of colorectal cancer, advanced adenomas, and matching control subjects have been enrolled. Under the current assumptions, 1,200 subjects will need to be enrolled.
Key inclusion criteria (8 listed)
- Must be 45-84 years of age.
- Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery.
- Able to comprehend, sign, and date the written informed consent document.
- Must be 45-84 years of age.
- Able and willing to undergo a standard-of-care screening colonoscopy within 60 days.
Key exclusion criteria (20 listed)
- 1. Subject with curative biopsy during colonoscopy.
- Subjects with positive FIT Test results in the 6 months preceding enrollment.
- Subject has a current diagnosis of cancer.
- Subject has a personal history of aerodigestive or digestive tract cancers.
- Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimization of Plasma Circulating Free-DNA (cfDNA) Marker PanelEvaluate the performance of a preliminary panel of biomarkers | Diagnostic test | Arm A., Arm B |
Primary outcome
Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing
Time frame: Within 12 months of sample collection
Samples Collected for Testing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (CRC) and Advanced Adenomas (AA), run by Universal Diagnostics at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Jesus Merino Calvo ((+34)674945571, antonio.merino@universaldx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing (time frame: Within 12 months of sample collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.