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
- 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 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.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProScreen, Protein Signature Based Screening of Colorectal Adenomas and Cancer
- ClinicalTrials.gov ID
- NCT07881549
- Acronym / sponsor ID
- ProScreen
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Keywords
- Proetin signatures, Colorectal cancer and adenomas
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Oct 2026 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- Scheduled for a coloscopy
Key exclusion criteria (1 listed)
- History of colorectal cancer, other cancer or inflammatory bowel disease
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
Differences in blood protein profiles between controls, participants with advanced colorectal adenomas, and participants with colorectal cancer
Time frame: At baseline, at the time of blood sample collection before colonoscopy; protein analyses performed after sample collection.
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.
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 19 Oct 2026.
- Individual participant dataSharing planned: 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.
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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.
Carl-Fredrik Rönnow, MD, PhD principal investigator
Region Skåne, Lund University
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 and Colorectal Adenoma, run by Region Skane at 1 site in Sweden.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 19 Oct 2026. 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 Sweden. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in blood protein profiles between controls, participants with advanced colorectal adenomas, and participants with colorectal cancer (time frame: At baseline, at the time of blood sample collection before colonoscopy; protein analyses performed after 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 19 Oct 2026.