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Tissue and Blood-based Biomarker in Colorectal Cancer

Investigating potential tissue and blood-based biomarkers from participants with various bowel pathologies, for the early detection of colorectal cancer in adults .

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000976886
Enrollment
834
Registered
2021-07-26
Start date
2013-07-30
Completion date
2029-12-31
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

This study is investigating whether known (already identified) or new potential biomarkers found in blood or tissue can be used to detect colorectal cancer, or to predict the outcomes of patients who have been diagnosed with colorectal cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have confirmed colorectal cancer or benign (non-cancerous) bowel disease or you are healthy without any history of bowel disease (cancerous or benign) Study details All participants who choose to enroll in this study will be asked to provide up to 6 blood samples over a 5 year period. Participants who have confirmed colorectal cancer will be asked to allow research on tissue collected at surgery or colonoscopy for 5 years post consent. Participants who have confirmed cancer will also be asked to share their medical history and any new test results with the research team to determine how the disease is responding to treatments provided. It is hoped this research will identify new biomarkers that may be used to improve health outcomes for colorectal cancer patients, either by allowing earlier detection of cancer, or by allowing detection of people who have a genetic risk of cancer so that they might take steps to reduce their future risk of developing cancer.

Interventions

Collection and analysis of tissue and blood samples from patients diagnosed with colorectal cancer, benign bowel disease and healthy volunteers (no bowel pathology) for the purpose of investigating the potential use of novel non-invasive biomarkers for screening, detection of recurrence, predicting clinical outcome and response to therapies. Participants may be asked to give serial blood samples for the purposes of monitoring biomarker changes over time. These samples will be taken at the same

Collection and analysis of tissue and blood samples from patients diagnosed with colorectal cancer, benign bowel disease and healthy volunteers (no bowel pathology) for the purpose of investigating the potential use of novel non-invasive biomarkers for screening, detection of recurrence, predicting clinical outcome and response to therapies. Participants may be asked to give serial blood samples for the purposes of monitoring biomarker changes over time. These samples will be taken at the same time as routine clinical assessments to avoid inconvenience to the participant. The schedule for blood collections will therefore differ depending on which pathology the participant has, and which biomarker is being investigated. All such information will be supplied to the participant at the time of consent. Any tissue samples to be used will be retrospectively sourced from pathology laboratories, using tissue that was taken for clinical care outside of this project. All tissue supplied will be de-identified before testing by research laboratories. Follow up data will be collected from hospital records from a participants clinical visit. All participants, regardless of pathology, will be followed up for a total of five years from first consent. Retrospective data relative to the project may be collected from a participants medical record after consent has been signed.

Sponsors

The Walter and Eliza Hall Institute of Medical Research (WEHI)
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Male and female 2. At least 18 years of age 3. Patients with histologically confirmed colorectal cancer, benign bowel disease or normal volunteers (no bowel pathology) 4. Provision of written informed consent where blood collection is required 5. Able to be accessible for follow up and data collection

Exclusion criteria

1. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol. 2. Patients who are not accessible for follow-up.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026