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FAQs for Researchers

Posted By ccwebsite On October 24, 2013 @ 3:00 pm In | Comments Disabled

Who is funding this study?

The CLEAR Study is funded by Cancer Council NSW.

Who are the investigators?

Principal Investigator Associate Professor Freddy Sitas, DPhil
Director, Cancer Research Division, Cancer Council NSW, Conjoint/Associate Professor, University of NSW /University of Sydney

Chief Investigators:

Professor Dianne O’Connell, BMaths (Hons), PhD Senior Epidemiologist, Cancer Research Division, Cancer Council NSW Associate Professor, University of Newcastle

Associate Professor Karen Canfell, DPhil
Senior Research Fellow and Group Leader, Cancer Modelling Group, Adult Cancer Program, Lowy Cancer Centre, University of New South Wales

Professor Michael Barton MBBS, FRANZCR Conjoint Associate Professor, School of Medicine, University of NSW and Research Director, Collaboration for Cancer Outcomes, Research and Evaluation Liverpool Health Service, NSW

Professor Emily Banks B MedSci, MBBS, PhD NHMRC Research Fellow and Study Director 45 and Up, National Centre for Epidemiology and Population Health, The Australian National University, ACT

Is there a study protocol available?

Please contact us on clearstudyenquiries@nswcc.org.au if you would like a copy of the CLEAR Study protocol.

Who are the study participants?

Study participants are people who have been diagnosed with a first primary cancer within the 18 months prior to receiving their invitation to enrol, and their cancer free partners. Eligibility of cases and controls is confirmed by linkage to the NSW Central Cancer Registry.

 Where have people been recruited?

Participants have been recruited via Clinical Cancer Registries, clinicians, a number of Cancer Council avenues, Melanoma Institute Australia and health insurance company HCF.

 How many participants are there?

In  2014 we have over 10,800 participants, approximately 8,000 cancer cases and 2,000 partner controls.

Is the study still recruiting? When will it stop recruiting?

Recruitment was placed on hold in early 2014 to enable review of the overall project. The current approved protocol aims for recruitment of 19,000 participants.

When were CLEAR Study patients diagnosed?

People have been enrolling in the study since 2006, so have been diagnosed since 2005.

At what stage were the patients recruited?

Patients have been recruited at any point up to 18 months from their initial diagnosis. Spread of disease for thse patients may be determined  by linkage to the NSW Central Cancer Registry.

 Does everyone in the study have cancer?

All our cases (n=7,456) have a diagnosis of a cancer type, while all our controls (n=2,069) are free of any cancer diagnosis up to the point of registering for this study.

Is the data ready?

Data has been prepared for release for  7,662 participants;  n= 5,896 cases and n= 1,766 controls. See table below for major cancer types. See Preliminary Data Book Dec 2013 for further detail.

Data cleaning is underway for core variables and priority questions for which there is active interest. CLEAR will be linked annually to the NSW Central Cancer Registry (CCR) to confirm cancer diagnosis, cancer type  and stage at diagnosis. Linkage with the CCR is up to date with the latest available cancer registrations until 2009. We also link to Registry of Births Death and Marriages and the Australian Bureau of Statistics for fact and cause of  deaths, respectively.

Major Cancer Types in Data Ready for Release at December 1, 2013

Breast

Bowel

Lung

Melanoma

Ovary

Prostate

Thyroid

Non Hodgkin’s Lymphoma

Male

7

440

114

223

0

975

28

85

Female

1504

338

129

233

124

0

117

93

Total

1511

778

243

456

124

975

145

178

What do I have to do to apply to use the study resource?

Applicants must complete the Application form available on the Researcher Toolkit page. For further enquiries now please email clearstudyenquiries@nswcc.org.au.

How much does it cost?

There is an application fee for applications for both data and blood specimens and a ccost recovery fee for provision of both data and bloods. Click here for the cost recovery fee structure. For enquiries now please email clearstudyenquiries@nswcc.org.au.

What linked data is available?

CLEAR Study is currently linked to the NSW Central Cancer Registry and to death records held by the Australian Bureau of Statistics and Register of Births, Deaths and Marriages. The study has consent from participants to link to other routinely collected data including clinical records, Medicare, Pharmaceutical Benefits Scheme and Admitted Patients Data Collection. Consent is also requested to access pathology data and dental records, and to data collected in the 45 and Up Study if the person is in both studies.

Researchers will require ethics approval from NSW Population Health Human Research Ethics Committee if they wish to access linked data.

 How did the CLEAR Study develop?

Click here to read about the CLEAR Study Provenance.

Are questions the same as for other large studies?

Many questions have been used in previous studies. There are questions in common with the 45 and Up Study and the Million Women Study.

 How many participants have given biological samples?

Provision of a blood sample is voluntary, however 75% of participants have provided a sample.

 What samples have been collected?

30ml blood is collected from each participant in ACD  and SST tubes. This is fractionated and stored as plasma, serum or buffy coat.

 What is the minimum data set to be provided with bloods?

A minimum data set will be provided with bloodsage, sex, date of diagnosis, cancer type, date of collection, time to processing.

Click here to see Researcher Toolkit.

Click here to go to Info for Researchers.


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