Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000987763
Ethics application status
Approved
Date submitted
2/09/2013
Date registered
4/09/2013
Date last updated
18/07/2022
Date data sharing statement initially provided
5/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A surveillance study investigating whole body magnetic resonance imaging and other diagnostic procedures in people at high risk of cancer
Scientific title
A surveillance study utilizing whole body magnetic resonance imaging and other surveillance procedures in people with germ line cancer gene mutations to investigate the prevalence and incidence of investigable lesions.
Secondary ID [1] 283124 0
None
Universal Trial Number (UTN)
Trial acronym
SMOC +
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 289974 0
Condition category
Condition code
Cancer 290345 290345 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Annual whole body magnetic resonance imaging, general physical exam, full blood count, and breast MRI, US and mammography(females). Other diagnostic procedures include colonoscopy and gastroscopy as indicated by family history. The study period is 3 years. Adherence to the study protocol will be monitored by accessing medical records.
Intervention code [1] 287844 0
Early detection / Screening
Intervention code [2] 287856 0
Diagnosis / Prognosis
Comparator / control treatment
Whole body magnetic resonance imaging performed in the general population as part of the Study of Health in Pomerania project (John U et al. Study of Health In Pomerania (SHIP): a health examination survery in an east German region: objectives and design. Soz Praventivmed 2001; 46: 186-194).
Control group
Historical

Outcomes
Primary outcome [1] 290376 0
Presence of at least one investigable lesion in a patient at baseline will be used to calculate the prevalence of investigable lesions by whole body MRI scan.
Timepoint [1] 290376 0
Baseline
Primary outcome [2] 290395 0
The presence of at least one new investigable lesion in a patient after 1, 2 and 3 years will be used to calculate the 1, 2 and 3 year incidences respectively by whole body MRI scan.
Timepoint [2] 290395 0
1, 2 and 3 years
Secondary outcome [1] 304375 0
The prevalence of investigable lesions by whole body MRI will be compared to a population based control group (SHIP) where healthy volunteers undergo whole body MRI.
Timepoint [1] 304375 0
1, 2 and 3 years
Secondary outcome [2] 304376 0
The number of primary lesions at baseline detected by whole body MRI.
Timepoint [2] 304376 0
Baseline
Secondary outcome [3] 304377 0
The number of new lesions after 1, 2 and 3 years of follow up as detected by whole body MRI, breast MRI, full blood evaluation, colonoscopy, endoscopy or any other clinically indicated diagnostic procedure.
Timepoint [3] 304377 0
1, 2 and 3 years
Secondary outcome [4] 304378 0
The number of cancers identified in each assessment and the correspondent tumor stage as detected by whole body MRI, breast MRI, full blood evaluation, colonoscopy, endoscopy or any other clinically indicated diagnostic procedure.
Timepoint [4] 304378 0
1, 2 and 3 years
Secondary outcome [5] 304379 0
Adherence to screening schedule and patient satisfaction will be assessed by monitoring medical records and asking patients to complete a modified breast screening satisfaction questionnaire.
Timepoint [5] 304379 0
1, 2 and 3 years
Secondary outcome [6] 304380 0
CTCAE v4 adverse events
Timepoint [6] 304380 0
1, 2 and 3 years
Secondary outcome [7] 304381 0
Changes in any of the following:
1. anxiety and depression (Hospital and Anxiety Depression Scale), in
2. worry about risk of developing cancer (Cancer Worry Scale), in
3. general health (Australian Quality of Life Instrument), in
4. self-perceived stress-related behaviour (Health Questionnaire), in
5. perceived risk of developing cancer, in state anxiety (Short Form STAI) and
6. extent to which signs or symptoms of intrusive thoughts are being felt (Impact of Events Scale).
Timepoint [7] 304381 0
1, 2 and 3 years
Secondary outcome [8] 304382 0
Costs (medical, personal, in direct) per individual of participating in a screening protocol assessed by a personal cost diary and Medicare PBS data.
Timepoint [8] 304382 0
3 years

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 age
18 Years
Maximum age
70 Years
Sex
Both 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible mutation carriers or family members at 50% risk of carrying a mutation will be
recruited from the familial cancer clinics (FCCs) by local FCC staff and eligible NF1 patients from specialist NF1 clinics.
A number of recruitment strategies will be employed; direct invitation during clinic appointment,
telephone as part of routine follow up processes of mutation carriers and their families.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/07/2013
Actual
9/07/2013
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
106
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1466 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 11666 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 11667 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 11668 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 19985 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 23712 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 23713 0
2031 - Randwick
Recruitment postcode(s) [3] 23714 0
3000 - Melbourne
Recruitment postcode(s) [4] 7301 0
3168 - Clayton
Recruitment postcode(s) [5] 34693 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 287875 0
Charities/Societies/Foundations
Name [1] 287875 0
Johanna Sewell Research Grant from the Johanna Sewell Memorial Fund
Country [1] 287875 0
Australia
Funding source category [2] 293164 0
Government body
Name [2] 293164 0
Cancer Australia
Country [2] 293164 0
Australia
Funding source category [3] 300408 0
Other Collaborative groups
Name [3] 300408 0
The Sydney Partnership for Health, Education, Research & Enterprise
Country [3] 300408 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Sarcoma Study Group
Address
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne
Victoria 3000
Country
Australia
Secondary sponsor category [1] 286602 0
None
Name [1] 286602 0
Address [1] 286602 0
Country [1] 286602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289818 0
Peter MacCallum Human Research Ethics Committee
Ethics committee address [1] 289818 0
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne
Victoria 3000
Ethics committee country [1] 289818 0
Australia
Date submitted for ethics approval [1] 289818 0
Approval date [1] 289818 0
09/07/2013
Ethics approval number [1] 289818 0
HREC/17/PMCC/143

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42574 0
A/Prof Paul James
Address 42574 0
Parkville Familial Cancer Centre
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne
Victoria 3000
Country 42574 0
Australia
Phone 42574 0
+61 3 8559 7283
Fax 42574 0
Email 42574 0
paul.james@petermac.org
Contact person for public queries
Name 42575 0
Dr Mandy Ballinger
Address 42575 0
The Kinghorn Cancer Centre, Garvan Institute of Medical Research, 370 Victoria Street, Darlinghurst, NSW 2010
Country 42575 0
Australia
Phone 42575 0
+61 2 9355 5806
Fax 42575 0
+61 2 9355 5872
Email 42575 0
m.ballinger@garvan.org.au
Contact person for scientific queries
Name 42576 0
A/Prof Paul James
Address 42576 0
Parkville Familial Cancer Centre
Peter MacCallum Cancer Centre
Grattan Street
Melbourne
Victoria 3000
Country 42576 0
Australia
Phone 42576 0
+61 3 8559 7283
Fax 42576 0
Email 42576 0
paul.james@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant privacy is at risk in rare syndromes


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4499Study protocol  m.ballinger@garvan.org.au
4500Ethical approval  m.ballinger@garvan.org.au


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIBreast cancer in patients with Li–Fraumeni syndrome – a case-series study and review of literature2017https://doi.org/10.2147/bctt.s134241
N.B. These documents automatically identified may not have been verified by the study sponsor.