Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

Launched by ORIGIN SCIENCES · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new test that analyzes rectal mucus to help detect colorectal cancer and significant polyps (which are growths that can become cancerous) in patients who have symptoms. The goal is to improve how doctors diagnose these conditions quickly and accurately for patients who are part of the 'urgent suspected cancer' pathway. The trial is currently recruiting participants aged 18 and older who have been referred for this evaluation.

To be eligible, participants must be able to provide written consent and should not have any conditions that would make it difficult or unsafe to perform a digital rectal examination (DRE). This includes certain anal or rectal issues, recent surgeries, or pregnancy. If you join the study, you'll undergo testing that focuses on the analysis of rectal mucus, which could lead to better ways of identifying colorectal cancer and polyps early. Your participation can help advance medical understanding and improve future patient care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients 18 years and over
• • 2. Patients referred from primary care to the 'urgent suspected cancer' CRC pathway during the study period.
• • 3. Patients who provide voluntary written informed consent to participate in the study.
• Exclusion Criteria:
• • 1. Patients who are unable to undergo digital rectal examination (DRE).
• 2. Patients with peri-anal/anal symptoms that may limit DRE and proctoscopy examination and it would be clinically inappropriate to attempt to assess these patients. This may include conditions such as:
• • Patients who have undergone radiotherapy.
• • An acute or chronic anal fissure
• • Perianal haematoma
• • Acute thrombosed haemorrhoids
• • Post- operative anal stenosis
• • The presence of an obstructing anal/low rectal tumour or discomfort as a result of previous pelvic radiotherapy
• • 3. Current pregnancy or suspicion of pregnancy.