None listed
Conditions
Brief summary
This study aims to find a simple and reliable way to identify which patients with rectal bleeding need an urgent colonoscopy. Rectal bleeding can be caused by bowel cancer or other conditions like haemorrhoids, and delays in diagnosis can occur because the symptom is not specific to cancer. Who is it for? You may be eligible for this study if you are aged 18 years and over who have been referred by their GP for rectal bleeding and are on a waiting list for an outpatient clinic appointment. Study details Participants who are eligible will be asked to complete 2 tests: A two-sample home stool test (similar to the one used in the national bowel cancer screening program). A blood test that looks for cancer-related changes in DNA. Participants will collect two stool samples at home and attend a study site for a blood sample. The stool sample will be tested for haemoglobin, and the blood sample will be tested for DNA methylation changes. All participants will also complete short health and wellbeing questionnaires at the time of testing and after their colonoscopy. If either test is positive, the participant will be offered an earlier colonoscopy. If both tests are negative, they will remain on the usual waiting list (standard care). This research hopes to improve how patients with rectal bleeding are prioritised for colonoscopy, helping to detect bowel cancer earlier and reduce waiting times for those at higher risk.
Interventions
This study involves the completion of two different biomarker tests to determine colonoscopy urgency in patients referred by GP for rectal bleeding. Individuals who are waiting for an outpatient clinic appointment at Flinders Medical Centre or Noarlunga Hospital because of a symptom of rectal bleeding will be invited into the study. Participant’s will be required to complete a self-collection two-sample faecal immunochemical test at home, and attend one study site visit for the collection of a b
This study involves the completion of two different biomarker tests to determine colonoscopy urgency in patients referred by GP for rectal bleeding. Individuals who are waiting for an outpatient clinic appointment at Flinders Medical Centre or Noarlunga Hospital because of a symptom of rectal bleeding will be invited into the study. Participant’s will be required to complete a self-collection two-sample faecal immunochemical test at home, and attend one study site visit for the collection of a blood sample. The faecal sample will be analysed for haemoglobin, and the blood sample will be analysed for methylation changes to DNA. Participants with analysed samples will be contacted with their results. Copies will also be distributed to the clinical teams and the patient’s GP. Those with a positive result in either biomarker test will be offered an earlier colonoscopy and those who are negative will remain on the outpatient list which is not a variation from standard clinical care. Participants will also be asked to complete a health questionnaire and a wellbeing survey at the time of their tests, as well as a follow-up wellbeing survey after their colonoscopy. It will take approximately 15 minutes per questionnaire/survey.
Sponsors
Southern Adelaide Local Health Network
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants include those who are: 1) over 18 years of age; 2) GP referred for rectal bleeding and on the waiting list for an outpatient clinic appointment; 3) willing to collect faecal samples and blood samples; and 4) able to complete questionnaires/surveys.
Exclusion criteria
Individuals will not be considered if they are unable to provide informed consent or have if comorbidities that will preclude from having colonoscopy.
Outcome results
None listed