Found this one too.First recuitment est 18/4/11 so not RHY related?
Development of a better screening test for bowel cancer.
Trial Information
Trial summary
This study aims to develop a more accurate screening test for colorectal cancer (CRC) by evaluating the accuracy of a panel of blood-based candidate biomarkers and to determine whether there is potential for recurrent cancers to be detected earlier with the new biomarker panel than the currently available blood tests. Who is it for? You may be eligible to join this study if you are aged 18 to 85 years old and are scheduled for colonoscopy for standard clinical indications.
Participants with a diagnosis of colorectal cancer (CRC) who have been treated and are being monitored for recurrence will also be eligible for the second and third phase of the study.
Study details: All participants in this study will be asked to undergo several tests for bowel cancer at the time of their routine hospital colonoscopy, the established gold standard bowel examination.
The tests include, blood and saliva samples; and faecal occult blood tests which we will compare to new tests that we are developing that detect specific markers in blood. If we can reliably detect these markers then we will be able to develop a better screening test for bowel cancer.
In patients who have been previously treated for bowel cancer and who are being monitored for signs of recurrence, we will also explore the use of the new biomarker blood test. It is hoped that this test may be more sensitive and detect recurrence much earlier than is now possible. The overall duration of observation in each participant is three years post surgery. For patients that undergo cancer resection prior to chemotherapy or radiotherapy, consent will be asked to obtain some tissue samples from any excess specimen from surgery (a cancer specimen and adjacent normal tissue). Tissue will have DNA extracted for analysis of biomarker levels to allow direct comparison to blood biomarker levels, as well as methylated BCAT1 and IKZF1 in the blood and surgical tissue. This will help to evaluate the accuracy and efficacy of the new blood-based screening test for bowel cancer.
Broad Health Conditioncolorectal cancer.
Specific Health ConditionCancer
Bowel - Back passage (rectum) or large bowel (colon)
Recruitment statusRecruiting
Recruitment Details
Recruitment State
SA
Hospital
Flinders Medical Centre - Bedford Park
Hospital
Repatriation Hospital - Daw Park
Hospital
Noarlunga Health Service - Noarlunga Centre
Postcode
5042
Postcode
5168 - Noarlunga Centre
Anticipated date of first participant enrolment18/04/2011
Anticipated date of last participant enrolment30/06/2020
Phase of Trial. ">Not Applicable
Has the study received ethics approval?Approved
Eligibility
Key inclusion criteria
Patients scheduled for colonoscopy for standard clinical indications.
Patients must be capable of providing satisfactory informed consent
In addition for Phase 2b
Cases with a diagnosis of CRC who have been treated and are being monitored for recurrence.
Cases where tumour tissues and/or blood samples with associated consent for use in research are available
Minimum age18 Years
Maximum age85 Years
GenderBoth males and females
Can Healthy volunteers participate?No
Key exclusion criteria
Inability to provide informed consent
Patients who undergo an incomplete colonoscopy which raises doubt as to the status of the colon (post-hoc exclusion).
Contact details and further information
SponsorPrimary Sponsor Type: Hospital
Primary Sponsor Name: Flinders Medical Centre
Primary Sponsor Address: 1 Flinders Drive Bedford Park 5042 South Australia
Primary Sponsor Country: Australia
Trial IDACTRN12611000318987
Contact person for information and recruitmentMs
Susie Byrne
Department of Gastroenterology, Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Bedford Park 5042
+61 8 8204 7402
+618 8204 6330
[email protected]
Australia
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