Management of the australianclinicaltrials.gov.au website has been transferred from NHMRC to the Commonwealth Department of Health. Disruption to site users as a consequence of this change should be minimal.

Clinical Trial Details

A surveillance study investigating whole body magnetic resonance imaging and other diagnostic procedures in people at high risk of cancer

Print record Print record
Trial Information

Broad Health Condition Cancer

Specific Health ConditionAny cancer

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Monash Medical Centre - Clayton campus - Clayton
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Prince of Wales Hospital - Randwick
Peter MacCallum Cancer Centre - Melbourne
The Royal Adelaide Hospital - Adelaide


Postcode
3168 - Clayton
2010 - Darlinghurst
2031 - Randwick
3000 - Melbourne
5000 - Adelaide

Anticipated date of first participant enrolment9/07/2013

Anticipated date of last participant enrolment9/07/2013

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

The study is investigating whole body magnetic resonance imaging (MRI) and other diagnostic procedures in people at high risk of cancer. Who is it for? You may be eligible to join this study if you are aged between 18-70 years, and are a known NF1 patient, OR a known cancer risk gene mutation carrier, OR have a family member at 50% risk of carrying a mutation. You will not be eligible if you have an active cancer diagnosis. Study details - All participants in this study will have an initial clinical review followed by annual diagnostic procedures for a period of 3 years. This may include annual whole body MRI scans, breast MRI (females only), fecal occult blood test and full blood count. Additional investigations including colonoscopy and upper gastrointestinal endoscopy may also be conducted at varying time points, as indicated by family history and clinical appropriateness. Participants will also be asked to complete psychosocial questionnaires and invited to participate in in-depth interviews. This study will provide estimates of the prevalence and incidence of investigable lesions, and the acceptability, safety, psychosocial impact, and cost-effectiveness of the screening protocol. This information will be used to design a large scale screening project.
Eligibility

Key inclusion criteria

Known cancer risk gene pathogenic mutation carrier or family member at 50% risk of carrying a mutation
ECOG performance status 0 or 1
No active cancer diagnosis. This is defined as the primary tumour having been treated
with no clinical or symptomatic evidence of metastatic disease
Expected lifespan greater than 3 years

Minimum age18 Years

Maximum age70 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Inability to provide informed consent
Serious co-morbid illness
Active cancer diagnosis
Inability to undergo study procedures
Inability to understand an English language consent form
Pregnancy
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Sarcoma Study Group
Primary Sponsor Address: Peter MacCallum Cancer Centre 305 Grattan Street Melbourne Victoria 3000
Primary Sponsor Country: Australia

Trial IDACTRN12613000987763

Contact person for information and recruitmentDr
Mandy Ballinger
The Kinghorn Cancer Centre, Garvan Institute of Medical Research, 370 Victoria Street, Darlinghurst, NSW 2010
+61 2 9355 5806
+61 2 9355 5872
Further information iconm.ballinger@garvan.org.au
Australia