Colorectal Cancer (Diagnosis)NCT07430527
Secondary Care Colorectal Cancer Pathway Review
An observational study of Colorectal Cancer (Diagnosis), run by University of Edinburgh at 2 sites in United Kingdom.
Trial summary
Bowel cancer (colorectal cancer) is the 4th most common cancer in Scotland. Approximately 4,000 cases are diagnosed annually. Cancer-related deaths in Scotland are higher than other UK nations. Improving the early detection of bowel cancer, and therefore survival, is important. 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 (Diagnosis)
- What is being tested?
- Faecal Immunohistochemical test
- How many people
- 25,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 May 2026to 31 Aug 2030
- 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: Adults referred to secondary-care with 'red-flag' gastrointestinal symptoms concerning for CRC.
Who may be able to join
- Patients managed within the NHS Lothian CRC USoC/urgent pathway (including urgent referrals) due to 'red-flag' symptoms concerning of CRC from April 2022 to August 2025.
Who cannot join
- Under the age of 18.
- History of inflammatory bowel disease.
- Under polyp surveillance.
- Previous diagnosis of CRC.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
NHS Lothian
Edinburgh
- Recruiting
NHS Lothian
Edinburgh
Farhat Din, 01316518500, Farhat.Din@ed.ac.uk
About this study
Official title: A Retrospective Review of the Secondary-care Colorectal Cancer Pathway Within NHS Lothian: An Evaluation of 3 Years of Pathway Performance
Bowel cancer (colorectal cancer) is the 4th most common cancer in Scotland. Approximately 4,000 cases are diagnosed annually. Cancer-related deaths in Scotland are higher than other UK nations. Improving the early detection of bowel cancer, and therefore survival, is important.
The majority of bowel cancers are diagnosed within secondary-care (colorectal surgery unit). Upon GP referral to secondary-care, patients provide stool samples which are analysed for microscopic blood (FIT; faecal immunohistochemical test). Patients with a single positive result are more likely to have bowel cancer (0.2% risk if no blood detected, but 8.4% if detected). A positive test triggers further investigation, either CT scan or colonoscopy depending on the result. Currently, colonoscopy and radiology services throughout Scotland are under significant pressure causing delays.
Read more
Only 2% of patients referred to secondary-care are diagnosed with bowel cancer, and most colonoscopies performed do not yield significant findings. We have shown that performing two repeated FITs upon referral improves cancer pickup rate (sensitivity) and reduces missed cancers. We successfully implemented this in NHS Lothian and contributed to national guidelines.
This study will undertake a comprehensive retrospective review of the double-FIT urgent suspicion of bowel cancer pathway within NHS Lothian, from April 2022 (date of pathway inception) to August 2025, including around 25,000 patients that have been managed through the pathway. We will calculate key performance indicators and diagnostic accuracy of the pathway. Health economic analysis will determine cost-per-diagnosis. Risk factors for bowel cancer in this patient cohort will be identified to develop a support tool for primary and secondary-care. These results will be used to develop a future pathway to optimise pathway efficiency and cancer detection.
Read the detailed description
Design:
This is a retrospective observational cohort data-analysis study of patients managed within the NHS Lothian colorectal cancer (CRC) urgent suspicion of cancer (USoC) pathway and patients referred urgently to the Colorectal department from April 2022 to August 2025. April 2022 corresponds to the start of double FIT testing within the pathway. 5-year follow-up will be included (up to August 2030) to include 5-year cancer outcomes.
Methods:
Patients will be identified from our pathway. Estimated ~25,000 patients will be included. Data will be collected on patient characteristics, past medical and prescribing history, hospital presentations and investigation outcomes, cancer outcomes and mortality data. Linkage to relevant patient datasets will be required.
A service review of the USoC/urgent pathway will focus on key performance indicators such as time to diagnosis and treatment, as well as patient journey pathways (Sankey plots) and re-referral rates.
Furthermore, data will be analysed using standard methods such as odds-ratio multivariate logistic regression to determine any significant associations which enrich for CRC and significant bowel pathology in this patient group. Significant bowel pathology includes advanced adenoma, advanced colorectal neoplasia and inflammatory bowel disease (IBD). Importantly, the modelling will only utilise readily available information from the electronic health record (EHR) such as age, sex, blood haemoglobin, BMI and SIMD to improve pre-test probability by restricting the target population.
Markov models will be formed as part of the health economic analysis, and the financial cost per case detected within the pathway will be calculated. We will explore the impact of waiting times on disease progression and the associated impact on the financial costs of treatment and patient quality of life.
Results from the above analyses will be incorporated into a decision-flow as guidance for referrals to secondary-care.
Sample size calculation:
To perform regression analysis, at a significance level of 0.05, medium size effect and 10 predictors, 170 cases of CRC are required. Our database of ~25,000 patients has approximately 500 cases of CRC. There will be minimal anticipated drop-out. Therefore our required sample size will be achievable.22
Proposed analyses:
Standard summary statistics of the pathway will be reported (means, standard deviations, medians, inter-quartile range). Multivariate logistic regression will be performed to determine risk-factors significant for CRC at different FIT levels. Subgroup analyses will take place within different FIT result thresholds (<10, 10-79, >79 µgHb/g) as well as between cancer and non-cancer patients, and for other significant bowel pathology. Long-term outcome data will be analysed, up to 5 years.
Furthermore, a service evaluation of the USoC/urgent pathway will focus on key performance indicators such as time to diagnosis and treatment, as well as patient journey pathways (Sankey plots) and re-referral rates. Markov models will be formed as part of the health economic analysis, and the financial cost per case detected within the pathway will be calculated. We will explore the impact of waiting times on disease progression and the associated impact on the financial costs of treatment and patient quality of life. The rate of interval cancers over long-term follow-up will be calculated.
We do not anticipate a significant amount of missing data. Data entries will be removed due to missing data on an analysis-by-analysis basis.
- Conditions
- Colorectal Cancer (Diagnosis)
- Being tested
- Faecal Immunohistochemical test
- Keywords
- Faecal immunohistochemical test, FIT
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal Immunohistochemical testDiagnostic test
Faecal Immunohistochemical test
| Study group | Role | What they receive |
|---|---|---|
| FIT non-returners | Referred patients who did not return FIT | |
| Single FIT returners | Referred patients who returned a single FIT Receives: Diagnostic Test: Faecal Immunohistochemical test | |
| Double FIT returners | Referred patients who returned two FITs Receives: Diagnostic Test: Faecal Immunohistochemical test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathway diagnostic accuracy
Sensitivity, specificity, NNI of pathway
Measured: 1 year
Secondary outcomes (1)
Cost per diagnosis
Cost per CRC diagnosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start6 May 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Retrospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430527
- Sponsor's protocol ID
- AC26020
- Status last verified
- Aug 2026
- First submitted
- 18 Feb 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD due to patient numbers and confidentiality
Publications
Perkmann T, Koller T, Perkmann-Nagele N, Ozsvar-Kozma M, Eyre D, Matthews P, Bown A, Stoesser N, Breyer MK, Breyer-Kohansal R, Burghuber OC, Hartl S, Aletaha D, Sieghart D, Quehenberger P, Marculescu R, Mucher P, Radakovics A, Klausberger M, Duerkop M, Holzer B, Hartmann B, Strassl R, Leitner G, Grebien F, Gerner W, Grabherr R, Wagner OF, Binder CJ, Haslacher H. Increasing test specificity without impairing sensitivity: lessons learned from SARS-CoV-2 serology. J Clin Pathol. 2023 Nov;76(11):770-777. doi: 10.1136/jcp-2022-208171. Epub 2022 Aug 30.
PubMed 36041815Cubiella J, Vega P, Salve M, Diaz-Ondina M, Alves MT, Quintero E, Alvarez-Sanchez V, Fernandez-Banares F, Boadas J, Campo R, Bujanda L, Clofent J, Ferrandez A, Torrealba L, Pinol V, Rodriguez-Alcalde D, Hernandez V, Fernandez-Seara J; COLONPREDICT study investigators. Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients. BMC Med. 2016 Aug 31;14(1):128. doi: 10.1186/s12916-016-0668-5.
PubMed 27580745Gerrard AD, Maeda Y, Miller J, Gunn F, Theodoratou E, Noble C, Porteous L, Glancy S, MacLean P, Pattenden R, Dunlop MG, Din FVN; Edinburgh Colorectal Group. Double faecal immunochemical testing in patients with symptoms suspicious of colorectal cancer. Br J Surg. 2023 Mar 30;110(4):471-480. doi: 10.1093/bjs/znad016.
PubMed 36785496Saw KS, Liu C, Xu W, Varghese C, Parry S, Bissett I. Faecal immunochemical test to triage patients with possible colorectal cancer symptoms: meta-analysis. Br J Surg. 2022 Feb 1;109(2):182-190. doi: 10.1093/bjs/znab411.
PubMed 34907419Pin-Vieito N, Tejido-Sandoval C, de Vicente-Bielza N, Sanchez-Gomez C, Cubiella J. Faecal immunochemical tests safely enhance rational use of resources during the assessment of suspected symptomatic colorectal cancer in primary care: systematic review and meta-analysis. Gut. 2022 May;71(5):950-960. doi: 10.1136/gutjnl-2021-324856. Epub 2021 Jun 9.
PubMed 34108236Bailey JA, Ibrahim H, Bunce J, Chapman CJ, Morling JR, Simpson JA, Humes DJ, Banerjea A. Quantitative FIT stratification is superior to NICE referral criteria NG12 in a high-risk colorectal cancer population. Tech Coloproctol. 2021 Oct;25(10):1151-1154. doi: 10.1007/s10151-021-02466-z. Epub 2021 Jul 14.
PubMed 34263362Cubiella J, Salve M, Diaz-Ondina M, Vega P, Alves MT, Iglesias F, Sanchez E, Macia P, Blanco I, Bujanda L, Fernandez-Seara J. Diagnostic accuracy of the faecal immunochemical test for colorectal cancer in symptomatic patients: comparison with NICE and SIGN referral criteria. Colorectal Dis. 2014 Aug;16(8):O273-82. doi: 10.1111/codi.12569.
PubMed 24456168Farkas N, O'Brien JW, Palyvos L, Maclean W, Benton S, Rockall T, Jourdan I. The increasing burden of the 2-week wait colorectal cancer pathway in a single centre: the impact of faecal immunochemical tests. Ann R Coll Surg Engl. 2024 Apr;106(4):338-343. doi: 10.1308/rcsann.2022.0138. Epub 2023 Jan 23.
PubMed 36688865Lemmon E, Hanna C, Diernberger K, Paterson HM, Wild SH, Ennis H, Hall PS. Variation in colorectal cancer treatment and outcomes in Scotland: real world evidence from national linked administrative health data. Int J Popul Data Sci. 2024 Feb 20;9(1):2179. doi: 10.23889/ijpds.v6i1.2179. eCollection 2024.
PubMed 38476269
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review of the Secondary-care Colorectal Cancer Pathway Within NHS Lothian: An Evaluation of 3 Years of Pathway Performance
- ClinicalTrials.gov ID
- NCT07430527
- Acronym / sponsor ID
- AC26020
- Conditions
- Colorectal Cancer (Diagnosis)
- Keywords
- Faecal immunohistochemical test, FIT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 24 Feb 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.
Bowel cancer (colorectal cancer) is the 4th most common cancer in Scotland. Approximately 4,000 cases are diagnosed annually. Cancer-related deaths in Scotland are higher than other UK nations. Improving the early detection of bowel cancer, and therefore survival, is important.
The majority of bowel cancers are diagnosed within secondary-care (colorectal surgery unit). Upon GP referral to secondary-care, patients provide stool samples which are analysed for microscopic blood (FIT; faecal immunohistochemical test). Patients with a single positive result are more likely to have bowel cancer (0.2% risk if no blood detected, but 8.4% if detected). A positive test triggers further investigation, either CT scan or colonoscopy depending on the result. Currently, colonoscopy and radiology services throughout Scotland are under significant pressure causing delays.
Only 2% of patients referred to secondary-care are diagnosed with bowel cancer, and most colonoscopies performed do not yield significant findings. We have shown that performing two repeated FITs upon referral improves cancer pickup rate (sensitivity) and reduces missed cancers. We successfully implemented this in NHS Lothian and contributed to national guidelines.
This study will undertake a comprehensive retrospective review of the double-FIT urgent suspicion of bowel cancer pathway within NHS Lothian, from April 2022 (date of pathway inception) to August 2025, including around 25,000 patients that have been managed through the pathway. We will calculate key performance indicators and diagnostic accuracy of the pathway. Health economic analysis will determine cost-per-diagnosis. Risk factors for bowel cancer in this patient cohort will be identified to develop a support tool for primary and secondary-care. These results will be used to develop a future pathway to optimise pathway efficiency and cancer detection.
Detailed description
Design:
This is a retrospective observational cohort data-analysis study of patients managed within the NHS Lothian colorectal cancer (CRC) urgent suspicion of cancer (USoC) pathway and patients referred urgently to the Colorectal department from April 2022 to August 2025. April 2022 corresponds to the start of double FIT testing within the pathway. 5-year follow-up will be included (up to August 2030) to include 5-year cancer outcomes.
Methods:
Patients will be identified from our pathway. Estimated ~25,000 patients will be included. Data will be collected on patient characteristics, past medical and prescribing history, hospital presentations and investigation outcomes, cancer outcomes and mortality data. Linkage to relevant patient datasets will be required.
A service review of the USoC/urgent pathway will focus on key performance indicators such as time to diagnosis and treatment, as well as patient journey pathways (Sankey plots) and re-referral rates.
Furthermore, data will be analysed using standard methods such as odds-ratio multivariate logistic regression to determine any significant associations which enrich for CRC and significant bowel pathology in this patient group. Significant bowel pathology includes advanced adenoma, advanced colorectal neoplasia and inflammatory bowel disease (IBD). Importantly, the modelling will only utilise readily available information from the electronic health record (EHR) such as age, sex, blood haemoglobin, BMI and SIMD to improve pre-test probability by restricting the target population.
Markov models will be formed as part of the health economic analysis, and the financial cost per case detected within the pathway will be calculated. We will explore the impact of waiting times on disease progression and the associated impact on the financial costs of treatment and patient quality of life.
Results from the above analyses will be incorporated into a decision-flow as guidance for referrals to secondary-care.
Sample size calculation:
To perform regression analysis, at a significance level of 0.05, medium size effect and 10 predictors, 170 cases of CRC are required. Our database of ~25,000 patients has approximately 500 cases of CRC. There will be minimal anticipated drop-out. Therefore our required sample size will be achievable.22
Proposed analyses:
Standard summary statistics of the pathway will be reported (means, standard deviations, medians, inter-quartile range). Multivariate logistic regression will be performed to determine risk-factors significant for CRC at different FIT levels. Subgroup analyses will take place within different FIT result thresholds (<10, 10-79, >79 µgHb/g) as well as between cancer and non-cancer patients, and for other significant bowel pathology. Long-term outcome data will be analysed, up to 5 years.
Furthermore, a service evaluation of the USoC/urgent pathway will focus on key performance indicators such as time to diagnosis and treatment, as well as patient journey pathways (Sankey plots) and re-referral rates. Markov models will be formed as part of the health economic analysis, and the financial cost per case detected within the pathway will be calculated. We will explore the impact of waiting times on disease progression and the associated impact on the financial costs of treatment and patient quality of life. The rate of interval cancers over long-term follow-up will be calculated.
We do not anticipate a significant amount of missing data. Data entries will be removed due to missing data on an analysis-by-analysis basis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FIT non-returners | – | –Referred patients who did not return FIT |
| Single FIT returners | – | Diagnostic Test: Faecal Immunohistochemical testReferred patients who returned a single FIT |
| Double FIT returners | – | Diagnostic Test: Faecal Immunohistochemical testReferred patients who returned two FITs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults referred to secondary-care with 'red-flag' gastrointestinal symptoms concerning for CRC.
Key inclusion criteria (1 listed)
- Patients managed within the NHS Lothian CRC USoC/urgent pathway (including urgent referrals) due to 'red-flag' symptoms concerning of CRC from April 2022 to August 2025.
Key exclusion criteria (4 listed)
- Under the age of 18.
- History of inflammatory bowel disease.
- Under polyp surveillance.
- Previous diagnosis 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faecal Immunohistochemical testFaecal Immunohistochemical test | Diagnostic test | Double FIT returners, Single FIT returners |
Primary outcome
Pathway diagnostic accuracy
Time frame: 1 year
Sensitivity, specificity, NNI of pathway
1 secondary outcome
Cost per diagnosis
Time frame: 1 year
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 28 Aug 2026.
- Background: PubMed 36041815Perkmann T, Koller T, Perkmann-Nagele N, Ozsvar-Kozma M, Eyre D, Matthews P, Bown A, Stoesser N, Breyer MK, Breyer-Kohansal R, Burghuber OC, Hartl S, Aletaha D, Sieghart D, Quehenberger P, Marculescu R, Mucher P, Radakovics A, Klausberger M, Duerkop M, Holzer B, Hartmann B, Strassl R, Leitner G, Grebien F, Gerner W, Grabherr R, Wagner OF, Binder CJ, Haslacher H. Increasing test specificity without impairing sensitivity: lessons learned from SARS-CoV-2 serology. J Clin Pathol. 2023 Nov;76(11):770-777. doi: 10.1136/jcp-2022-208171. Epub 2022 Aug 30.
- Background: PubMed 27580745Cubiella J, Vega P, Salve M, Diaz-Ondina M, Alves MT, Quintero E, Alvarez-Sanchez V, Fernandez-Banares F, Boadas J, Campo R, Bujanda L, Clofent J, Ferrandez A, Torrealba L, Pinol V, Rodriguez-Alcalde D, Hernandez V, Fernandez-Seara J; COLONPREDICT study investigators. Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients. BMC Med. 2016 Aug 31;14(1):128. doi: 10.1186/s12916-016-0668-5.
- Background: PubMed 36785496Gerrard AD, Maeda Y, Miller J, Gunn F, Theodoratou E, Noble C, Porteous L, Glancy S, MacLean P, Pattenden R, Dunlop MG, Din FVN; Edinburgh Colorectal Group. Double faecal immunochemical testing in patients with symptoms suspicious of colorectal cancer. Br J Surg. 2023 Mar 30;110(4):471-480. doi: 10.1093/bjs/znad016.
- Background: PubMed 34907419Saw KS, Liu C, Xu W, Varghese C, Parry S, Bissett I. Faecal immunochemical test to triage patients with possible colorectal cancer symptoms: meta-analysis. Br J Surg. 2022 Feb 1;109(2):182-190. doi: 10.1093/bjs/znab411.
- Background: PubMed 34108236Pin-Vieito N, Tejido-Sandoval C, de Vicente-Bielza N, Sanchez-Gomez C, Cubiella J. Faecal immunochemical tests safely enhance rational use of resources during the assessment of suspected symptomatic colorectal cancer in primary care: systematic review and meta-analysis. Gut. 2022 May;71(5):950-960. doi: 10.1136/gutjnl-2021-324856. Epub 2021 Jun 9.
- Background: PubMed 34263362Bailey JA, Ibrahim H, Bunce J, Chapman CJ, Morling JR, Simpson JA, Humes DJ, Banerjea A. Quantitative FIT stratification is superior to NICE referral criteria NG12 in a high-risk colorectal cancer population. Tech Coloproctol. 2021 Oct;25(10):1151-1154. doi: 10.1007/s10151-021-02466-z. Epub 2021 Jul 14.
- Background: PubMed 24456168Cubiella J, Salve M, Diaz-Ondina M, Vega P, Alves MT, Iglesias F, Sanchez E, Macia P, Blanco I, Bujanda L, Fernandez-Seara J. Diagnostic accuracy of the faecal immunochemical test for colorectal cancer in symptomatic patients: comparison with NICE and SIGN referral criteria. Colorectal Dis. 2014 Aug;16(8):O273-82. doi: 10.1111/codi.12569.
- Background: PubMed 36688865Farkas N, O'Brien JW, Palyvos L, Maclean W, Benton S, Rockall T, Jourdan I. The increasing burden of the 2-week wait colorectal cancer pathway in a single centre: the impact of faecal immunochemical tests. Ann R Coll Surg Engl. 2024 Apr;106(4):338-343. doi: 10.1308/rcsann.2022.0138. Epub 2023 Jan 23.
- Background: PubMed 38476269Lemmon E, Hanna C, Diernberger K, Paterson HM, Wild SH, Ennis H, Hall PS. Variation in colorectal cancer treatment and outcomes in Scotland: real world evidence from national linked administrative health data. Int J Popul Data Sci. 2024 Feb 20;9(1):2179. doi: 10.23889/ijpds.v6i1.2179. eCollection 2024.
- Cancer Research UK (CRUK). Bowel cancer statistics \[Internet\]. Cancer Research UK. Published 2024Link provided by the sponsor.
- The Scottish Government. Quantitative Faecal Immunochemical Test (qFIT) for Patients with Colorectal Symptoms Guidance for Primary Care \[Internet\]. The Scottish Government. Published 2022Link provided by the sponsor.
- National Institute for Health and Care Research. Clinical decision support tools. \[Internet\]. National Institute for Health and Care Research. Published 2020Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share IPD due to patient numbers and confidentiality
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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.
2 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 (Diagnosis), run by University of Edinburgh at 2 sites in United Kingdom.
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 4 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathway diagnostic accuracy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07430527, which also lists 9 linked publications.
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 28 Aug 2026.