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Trial registered on ANZCTR


Registration number
ACTRN12610000120077
Ethics application status
Approved
Date submitted
1/02/2010
Date registered
4/02/2010
Date last updated
4/09/2019
Date data sharing statement initially provided
4/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
International Sarcoma Kindred Study: Identification of inherited risk in individuals with sarcoma
Scientific title
Identification of inherited risk in individuals with sarcoma to aid in the creation of a research resource consisting of biospecimens and associated data
Secondary ID [1] 1367 0
None
Universal Trial Number (UTN)
U1111-1113-4959
Trial acronym
ISKS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sarcoma 256694 0
genetic mutations 256701 0
Condition category
Condition code
Cancer 256848 256848 0 0
Sarcoma (also see 'Bone') - soft tissue
Human Genetics and Inherited Disorders 256849 256849 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will provide a blood sample (& tissue sample if uncompromised by pre-operative treatment at the time of surgery) and health and epidemiological information once upon enrolment. The study is anticipated to be ongoing.
Intervention code [1] 255928 0
Not applicable
Comparator / control treatment
Matched individuals with no incidence of cancer
Control group
Active

Outcomes
Primary outcome [1] 257721 0
Creation of a research resource consisting of biospecimens and associated clinical data and information from 3000 individuals and their families
Timepoint [1] 257721 0
At 7 years from commencement of the study
Primary outcome [2] 257755 0
Development of clinically useful population based criteria for stratifying genetic or hereditary risk for adult-onset sarcoma
Timepoint [2] 257755 0
At 7 years from commencement of the study
Primary outcome [3] 257757 0
Mapping genetic mutations in patients with adult-onset sarcoma using linkage analysis and next generation sequencing
Timepoint [3] 257757 0
At 2-5 years from the commencement of the study
Secondary outcome [1] 263144 0
Evaluation of community attitudes to genetic research and testing in the setting of sarcoma using a questionnaire
Timepoint [1] 263144 0
At 2-3 years from the commencement of the study

Eligibility
Key inclusion criteria
All those diagnosed with sarcoma are eligible for inclusion. Controls must be age matched within 5 years of the proband, be older than or equal to 18 years of age, not have had a cancer diagnosis and not be a blood relative.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Controls must be older than or equal to 18 years of age

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
8/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
2800
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 7713 0
United Kingdom
State/province [1] 7713 0
London
Country [2] 7714 0
India
State/province [2] 7714 0
Mumbai
Country [3] 7715 0
France
State/province [3] 7715 0
Lyon
Country [4] 7716 0
United States of America
State/province [4] 7716 0
Utah
Country [5] 7717 0
Korea, Republic Of
State/province [5] 7717 0
Seoul
Country [6] 7718 0
New Zealand
State/province [6] 7718 0
Canterbury

Funding & Sponsors
Funding source category [1] 256423 0
Charities/Societies/Foundations
Name [1] 256423 0
Rainbows for Kate Foundation
Country [1] 256423 0
Australia
Funding source category [2] 293165 0
Government body
Name [2] 293165 0
Victorian Cancer Agency
Country [2] 293165 0
Australia
Funding source category [3] 293166 0
Charities/Societies/Foundations
Name [3] 293166 0
Liddy Shriver Sarcoma Initiative
Country [3] 293166 0
United States of America
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] 291959 0
None
Name [1] 291959 0
Address [1] 291959 0
Country [1] 291959 0
Other collaborator category [1] 278907 0
Individual
Name [1] 278907 0
Isabelle Ray-Coquard
Address [1] 278907 0
Centre Leon Berard, 28 Prom. Lea et Napolean Bullukian, 69008 Lyon, France
Country [1] 278907 0
France
Other collaborator category [2] 278908 0
Individual
Name [2] 278908 0
Winette van der Graaf
Address [2] 278908 0
Royal Marsden Hospital, Fulham Rd, London SW3 6JJ, UK
Country [2] 278908 0
United Kingdom
Other collaborator category [3] 278909 0
Individual
Name [3] 278909 0
Joshua Schiffman
Address [3] 278909 0
Hunstman Cancer Institute, 2000 Circle of Hope Drive, Salt Lake City, UT 84112, USA
Country [3] 278909 0
United States of America
Other collaborator category [4] 278910 0
Individual
Name [4] 278910 0
Robert Maki
Address [4] 278910 0
Mount Sinai Hospital, One Gustave L. Levy Place
New York, NY 10029-6574, USA
Country [4] 278910 0
United States of America
Other collaborator category [5] 278911 0
Individual
Name [5] 278911 0
Ajay Puri
Address [5] 278911 0
Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai, Maharashtra 400012, India
Country [5] 278911 0
India
Other collaborator category [6] 278912 0
Individual
Name [6] 278912 0
JinHee Ahn
Address [6] 278912 0
Asan Medical Centre, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
Country [6] 278912 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258473 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 258473 0
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne
Victoria 3000
Ethics committee country [1] 258473 0
Australia
Date submitted for ethics approval [1] 258473 0
Approval date [1] 258473 0
14/04/2009
Ethics approval number [1] 258473 0
9/11/2010
Ethics committee name [2] 258474 0
NSW Population & Health Services Research Ethics Committee
Ethics committee address [2] 258474 0
Cancer Institute NSW
Australian Technology Park
Biomedical Building
PO Box 41
Alexandria
NSW 1435
Ethics committee country [2] 258474 0
Australia
Date submitted for ethics approval [2] 258474 0
Approval date [2] 258474 0
06/08/2009
Ethics approval number [2] 258474 0
HREC/09/CIPHS/34
Ethics committee name [3] 258475 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [3] 258475 0
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD 4102
Ethics committee country [3] 258475 0
Australia
Date submitted for ethics approval [3] 258475 0
Approval date [3] 258475 0
16/06/2009
Ethics approval number [3] 258475 0
2009/104
Ethics committee name [4] 258476 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [4] 258476 0
PO Box 499
Toowong
QLD 4066
Ethics committee country [4] 258476 0
Australia
Date submitted for ethics approval [4] 258476 0
Approval date [4] 258476 0
26/06/2009
Ethics approval number [4] 258476 0
0918

Summary
Brief summary
This study aims to identify inherited risk in individuals with sarcoma to aid in the creation of a research resource consisting of biospecimens and associated data.
Who is it for?
You may be eligible to join this study if you have been diagnosed with sarcoma.
Study details
Participants will be identified at key sarcoma clinics, asked to complete a questionnarie and provide biospecimens (blood and tissue). The biospecimens will be stored indefinitely in a tissue bank to be utilised by researchers investigating genetic factors contributing to cancer. Information obtained from the questionnaire will be used to ascertain the family history of cancer and other factors that may contribute to development of the disease. The ongoing nature of the project will enable continual provision of important practical information for clinicians and patients leading to more favourable outcomes.
Sarcomas contribute disproportionately to cancer burden in our community, because they affect the young, treatment is costly and prolonged and morbidity and mortality is high. Genetic factors appear important in sarcomas, although they have not been well studied for the adult population. Early detection by identifying those at risk may lead to better prognoses. This project aims to create a vital research resource to enable further study into the genetic factors contributing to the hereditary risk of developing sarcoma.
Trial website
www.australiansarcomagroup.org/sarcomakindredstudy/
Trial related presentations / publications
Downing et al. An increased incidence of Hodgkin’s lymphoma in patients with adult-onset sarcoma. Clinical Sarcoma Research 2012, 2:1
Young et al. The attitudes of people with sarcoma and their family towards genomics and incidental information arising from genetic research. Clinical Sarcoma Research 2013, 3:11
Savage et al. Genome-wide association study identifies two susceptibility loci for osteosarcoma. Nature Genetics 2013, 45(7):799-803
Mitchell et al. High frequency of germline TP53 mutations in a prospective adult-onset sarcoma cohort. PLOS One 2013, 8(7): e69026
Ballinger et al. Monogenic and polygenic determinants of sarcoma risk: an international genetic study. Lancet Oncology 2016, 17(9):1261-71
Public notes

Contacts
Principal investigator
Name 30776 0
Prof David Thomas
Address 30776 0
The Kinghorn Cancer Centre, Garvan Institute of Medical Research, 370 Victoria Street, Darlinghurst, NSW 2010
Country 30776 0
Australia
Phone 30776 0
61 2 9355 5770
Fax 30776 0
Email 30776 0
d.thomas@garvan.org.au
Contact person for public queries
Name 14023 0
Dr Mandy Ballinger
Address 14023 0
The Kinghorn Cancer Centre, Garvan Institute of Medical Research, 370 Victoria Street, Darlinghurst, NSW 2010
Country 14023 0
Australia
Phone 14023 0
+61 2 9355 5806
Fax 14023 0
+61 2 9355 5872
Email 14023 0
m.ballinger@garvan.org.au
Contact person for scientific queries
Name 4951 0
Dr Mandy Ballinger
Address 4951 0
The Kinghorn Cancer Centre, Garvan Institute of Medical Research, 370 Victoria Street, Darlinghurst, NSW 2010
Country 4951 0
Australia
Phone 4951 0
+61 417 546042
Fax 4951 0
+61 2 9355 5872
Email 4951 0
m.ballinger@garvan.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.