Cancer detection by analysing non-invasively collected colorectal mucus

Colorectal cancer detection by quantifying biomarkers in non-invasively collected colorectal mucus: an observational case-control study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16782445

Enrollment

150

Registered

2016-11-15

Start date

2017-01-15

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer Cancer

Interventions

At the initial (pilot) stage of this observational case-control study it is planned to recruit at least 50 patients with colorectal cancer (between diagnostic colonoscopy and surgery) and 50 neoplasia

possibly PCR-based techniques for DNA and RNA) and cytological examination. All analytical procedures are blinded with regard to patient identity and diagnosis. At the end of the study the results of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Colorectal cancer (case) group: the presence of endoscopically confirmed colorectal cancer 2. Control group: absence of neoplasia confirmed by endoscopy 3. Aged over 45

Exclusion criteria

Exclusion criteria: 1. Age below 45 2. The presence of active gastrointestinal diseases or major gastrointestinal surgery in the past 3. Ongoing treatment with hormonal, immunosuppresive or cytostatic drugs

Design outcomes

Primary

Measure	Time frame
All results will be obtained at a single time point. Protein biomarkers: 1. Calprotectin measured using ELISA 2. EDN measured using ELISA 3. MUC2 measured using ELISA 4. MMP9 measured using ELISA 5. VEGF measured using ELISA 6. Soluble Cytokeratin 18 measured using ELISA 7. M2-PK measured using ELISA 8. Haemoglobin measured using ELISA 9. Measurement of additional protein biomarkers may be introduced at later stages of the project Nucleic acid markers: 1. Total DNA measured by spectrophotometry 2. Total DNA measured by real time PCR (beta-globin gene fragment amplification) 3. Measurement of additional DNA & RNA markers may be introduced at later stages of the project Cytology and immunocytochemistry: 1. Qualitative cytological examination of collected samples using microscopy 2. Immunocytochemical visualisation of protein biomarkers and qualitative assessment of their distribution using microscopy	—

Measure

Time frame

All results will be obtained at a single time point. Protein biomarkers: 1. Calprotectin measured using ELISA 2. EDN measured using ELISA 3. MUC2 measured using ELISA 4. MMP9 measured using ELISA 5. VEGF measured using ELISA 6. Soluble Cytokeratin 18 measured using ELISA 7. M2-PK measured using ELISA 8. Haemoglobin measured using ELISA 9. Measurement of additional protein biomarkers may be introduced at later stages of the project Nucleic acid markers: 1. Total DNA measured by spectrophotometry 2. Total DNA measured by real time PCR (beta-globin gene fragment amplification) 3. Measurement of additional DNA & RNA markers may be introduced at later stages of the project Cytology and immunocytochemistry: 1. Qualitative cytological examination of collected samples using microscopy 2. Immunocytochemical visualisation of protein biomarkers and qualitative assessment of their distribution using microscopy

—

Secondary

Measure	Time frame
Performance of each of the biomarkers/assays listed above as a diagnostic test comparing CRC presence versus CRC absence, measured by ROC (receiver operating characteristic) curve analysis (area under the curve, sensitivity, specificity) and calculation of test negative and positive predictive values as well as positive and negative likelihood ratios	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026