Detection of bowel cancer using urinary biomarkers

Detection of symptomatic colorectal cancer using volatile urinary biomarkers (DISCOVER)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN39793686

Enrollment

600

Registered

2019-02-27

Start date

2018-07-01

Completion date

Unknown

Last updated

2020-04-27

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

Conditions

Colorectal cancer Cancer

Interventions

This observational study is investigating the feasibility of a larger study looking into the use of urinary volatile compounds in the assessment of patients with symptoms of bowel cancer. Patients ref

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 years and over 2. Referred by their GP for fast-track assessment due to symptoms of colorectal cancer

Exclusion criteria

Exclusion criteria: 1. Patients unable to provide written informed consent 2. Current proven urinary tract infection 3. Urine sample dipstick testing positive for nitrites 4. Antibiotic use for any reason within the past fourteen days 5. Any contraindication to colonoscopy or CT colonography 6. Any other proven or suspected cancer (except non melanoma skin cancer) 7. Patients undergoing renal replacement therapy 8. Patients with ileal conduit due to cystectomy 9. Patients with urinary catheter, urethral or suprapubic 10. Inability to provide a midstream urine sample

Design outcomes

Primary

Measure	Time frame
The primary outcome will consist of feasibility outcomes including recruitment rate, attrition rate (this is unlikely to relate to the patients since there isn’t any follow up involving patients, but rather to loss of urine samples of problems with processing), logistics of storage and transport of urine samples, piloting of clinical data collection (extraction of disease status data from clinical records). Another important outcome from this study is the assessment of the specificity and sensitivity of the gas chromatography techniques used in the study. These will be compared using both quantitative output data as well as logistical and technical considerations relating to their use in clinical practice. This assessment will inform the choice of which chromatography technique to take forward into a larger study.	—

Measure

Time frame

The primary outcome will consist of feasibility outcomes including recruitment rate, attrition rate (this is unlikely to relate to the patients since there isn’t any follow up involving patients, but rather to loss of urine samples of problems with processing), logistics of storage and transport of urine samples, piloting of clinical data collection (extraction of disease status data from clinical records). Another important outcome from this study is the assessment of the specificity and sensitivity of the gas chromatography techniques used in the study. These will be compared using both quantitative output data as well as logistical and technical considerations relating to their use in clinical practice. This assessment will inform the choice of which chromatography technique to take forward into a larger study.

—

Secondary

Measure	Time frame
Detection of urinary volatile biomarkers able to identify patients with colorectal cancer	—

Countries

United Kingdom

Outcome results

None listed

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