Colorectal CancerNCT07881549
Protein Signature Based Screening of Colorectal Adenomas and Cancer
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Region Skane at 1 site in Sweden.
Trial summary
Colorectal cancer is a common cancer, that in general develops over a long time period (approximately 10-15 years) from precancerous polyps. The disease is in many cases asymptomatic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 9 Oct 2026to Mar 2028
- Phase
- Observational
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for a colonoscopy due to a positive FIT test taken in the national screening program or patients with confirmed colorectal adenomas or cancer will be invited to participate in the study
Who may be able to join
- Scheduled for a coloscopy
Who cannot join
- History of colorectal cancer, other cancer or inflammatory bowel disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ProScreen, Protein Signature Based Screening of Colorectal Adenomas and Cancer
Colorectal cancer is a common cancer, that in general develops over a long time period (approximately 10-15 years) from precancerous polyps. The disease is in many cases asymptomatic. Colonoscopy allows doctors to examine the colon and rectum and identify colorectal cancer and/or precancerous growths, such as advanced adenomas. However, better methods are needed to identify patients that have precancerous lesions and early colorectal cancer and to understand the biological changes associated with these conditions.
The ProScreen study aims to investigate whether proteins measured in a blood sample can help distinguish between people with advanced precancerous growths, people with colorectal cancer, and people without these conditions.
Read more
In this first study, patients scheduled to undergo colonoscopy will be invited to participate and provide a blood sample. Participants will be classified according to the findings of their clinical examinations. Blood samples will be analyzed to measure multiple proteins and identify protein patterns associated with advanced precancerous growths and colorectal cancer.
The study does not involve an experimental treatment. The results may contribute to the development of improved blood tests for colorectal cancer prevention and early detection in the future.
Read the detailed description
ProScreen Study I is a prospective, exploratory cohort study conducted at Skåne University Hospital, Sweden. The study aims to identify blood-based protein profiles associated with advanced colorectal adenomas and colorectal cancer, with the long-term goal of contributing to the development of improved methods for colorectal cancer prevention and early detection.
Patients scheduled for colonoscopy, as well as patients with confirmed colorectal lesions, will be invited to participate. After providing informed consent, participants will provide a blood sample specifically for research purposes. Blood will be collected using the Capitainer quantitative dried blood spot (qDBS) method, which enables standardized sampling of a small volume of blood. The research sampling is performed in addition to routine clinical care and does not alter the participants' diagnostic procedures or treatment.
The dried blood spot samples will be analyzed using proximity extension assay (PEA) technology and the Olink Explore HT platform to measure a large number of proteins simultaneously. Protein abundance will be compared across the study groups to identify proteins and combinations of proteins associated with advanced colorectal adenomas and colorectal cancer.
Statistical analyses will include comparisons of protein levels between groups and the development of multivariable predictive models using penalized regression methods, including glmnet. The diagnostic performance of candidate protein signatures will be evaluated using receiver operating characteristic (ROC) curves and the area under the ROC curve (AUC), together with estimates of sensitivity and specificity where appropriate.
An interim analysis is planned after the first 100 participants have been evaluated. The findings will be used to assess the feasibility of the analytical approach and inform subsequent development and validation within the broader ProScreen research programme.
This study involves no experimental treatment. Its purpose is to investigate associations between blood protein profiles and colorectal disease status. The findings may provide a basis for future studies evaluating blood-based tests for the detection of advanced precancerous lesions and colorectal cancer.
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Keywords
- Proetin signatures, Colorectal cancer and adenomas
- Medical subject headings
- Colorectal Neoplasms, Adenoma
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 |
|---|---|---|
| Control group | No adenomas or colorectal cancer found during colonoscopy | |
| Advanced adenomas | Finding of an advanced adenoma defined as >1cm and or high grade dysplasia, or >5 adenomas | |
| Colorectal cancer | Colorectal cancer detected during colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in blood protein profiles between controls, participants with advanced colorectal adenomas, and participants with colorectal cancer
Relative protein levels measured using proximity extension assay (PEA) and the Olink Explore platform will be compared between three groups: controls, participants with advanced colorectal adenomas, and participants with biopsy-confirmed colorectal cancer. Protein profiles will be evaluated to identify differences in protein abundance between the groups.
Measured: At baseline, at the time of blood sample collection before colonoscopy; protein analyses performed after sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start9 Oct 2026
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl-Fredrik Rönnow, MD, PhD, Principal investigator, Region Skåne, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881549
- Sponsor's protocol ID
- ProScreen
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding sharing of individual participant data has not yet been made. Any future data sharing will be considered in accordance with applicable data protection regulations, ethical approvals, informed consent, and institutional policies.