An observational study in Colorectal Cancer and Colorectal Adenoma, sponsored by Region Skane. Enrolling by invitation at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Region Skane · Observational
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.
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.
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.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 150 is below the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Region Skane is the lead sponsor of 382 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No adenomas or colorectal cancer found during colonoscopy
Finding of an advanced adenoma defined as \>1cm and or high grade dysplasia, or \>5 adenomas
Colorectal cancer detected during colonoscopy
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.
Time frame: At baseline, at the time of blood sample collection before colonoscopy; protein analyses performed after sample collection.
Plan to share: 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.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2027, 12 months after the start.
Of 461 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 132. This study's planned 12 months is below that.
Counting every sponsor, half of 562 studies reached it within 53 months; a quarter within 28 and three quarters within 103.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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