Colorectal CancerPROVENCT07310446
Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance
An observational study of Colorectal Cancer, run by Universal Diagnostics at 1 site in United States.
Trial summary
This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic… 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
- How many people
- 6,500 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2023to Jul 2027
- 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: Prevalent colorectal cancer and people undergoing screening for colorectal cancer
Who may be able to join
- Arm A: Diagnosed with CRC
- Arm B: Undergoing screening with colonoscopy for CRC
Who cannot join
- Arm A: Undergoing treatment for CRC,
- Arm B: Past history of CRC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Gastroenterology and Internal Medicine Specialists
Lake Barrington, Illinois, 60010
Manish Bhuva, MD, 8473824410, prove@universaldx.com
Manish Bhuva, MD
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 (PROVE)
This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pr e- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.
Read the detailed description
The Sponsor has identified cfDNA (circulating free-DNA) alterations (including methylation, fragmentation, and copy-number variance) that allow specific detection of colorectal cancer (CRC) advanced precancerous lesions (APL) and is in the process of developing a bloodbased test for early detection of colorectal cancer. The Sponsor is performing the current study to evaluate and optimize the performance of a preliminary panel of markers to finalize the assay for the use for US population. This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pre- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.
- Conditions
- Colorectal Cancer
- Keywords
- colorectal, screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Patients newly diagnosed with CRC who have not yet had treatment or surgery. | |
| Arm B | People at average risk of CRC undergoing screening for colorectal cancer with colonoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of assay
The primary objective of this study is to optimize and evaluate the performance, including sensitivity and specificity, of the preliminary cfDNA marker panel to detect CRC and APL.
Measured: Baseline
Secondary outcomes (1)
ML Training
A portion of the samples will be used to train the ML algorithms and for assay development activities. Another purpose of the study is to collect samples to be used in Analytical Validation (Assay Verification) and system validation.
Measured: Through study completion to extend up to 24 months post LPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start31 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Retrospective
- Enrolment
- 6,500 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
- NCT07310446
- Sponsor's protocol ID
- CRC-US-002
- Acronym
- PROVE
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Company IP.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 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 (PROVE)
- ClinicalTrials.gov ID
- NCT07310446
- Acronym / sponsor ID
- PROVE / CRC-US-002
- Conditions
- Colorectal Cancer
- Keywords
- colorectal, screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- Universal DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Dec 2025 (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.
This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pr e- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.
Detailed description
The Sponsor has identified cfDNA (circulating free-DNA) alterations (including methylation, fragmentation, and copy-number variance) that allow specific detection of colorectal cancer (CRC) advanced precancerous lesions (APL) and is in the process of developing a bloodbased test for early detection of colorectal cancer. The Sponsor is performing the current study to evaluate and optimize the performance of a preliminary panel of markers to finalize the assay for the use for US population. This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pre- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | –Patients newly diagnosed with CRC who have not yet had treatment or surgery. |
| Arm B | – | –People at average risk of CRC undergoing screening for colorectal cancer with colonoscopy. |
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prevalent colorectal cancer and people undergoing screening for colorectal cancer
Key inclusion criteria (2 listed)
- Arm A: Diagnosed with CRC
- Arm B: Undergoing screening with colonoscopy for CRC
Key exclusion criteria (2 listed)
- Arm A: Undergoing treatment for CRC,
- Arm B: Past history of CRC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of assay
Time frame: Baseline
The primary objective of this study is to optimize and evaluate the performance, including sensitivity and specificity, of the preliminary cfDNA marker panel to detect CRC and APL.
1 secondary outcome
ML Training
Time frame: Through study completion to extend up to 24 months post LPI
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 30 Dec 2025.
- Individual participant dataSharing planned: No. Company IP.
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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.
1 site 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, run by Universal Diagnostics at 1 site 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 2 inclusion and 2 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (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?
Development of assay (time frame: Baseline). 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 30 Dec 2025.