Clinical Trial Details

Development of a better screening test for bowel cancer.

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionBowel - Back passage (rectum) or large bowel (colon)

Trial Focus

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Hospital
Flinders Medical Centre - Bedford Park
Repatriation Hospital - Daw Park
Noarlunga Health Service - Noarlunga Centre
The Queen Elizabeth Hospital - Woodville
Lyell McEwin Hospital - Elizabeth Vale


Postcode
5042
5168 - Noarlunga Centre
5011 - Woodville
5112 - Elizabeth Vale

Anticipated date of first participant enrolment18/04/2011

Anticipated date of last participant enrolment18/04/2011

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

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.
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

Sponsor Primary 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
Further information iconsusie.byrne@sa.gov.au
Australia