Info for researchers

CLEAR Study Publications

What factors do cancer patients believe contribute to the development of their cancer?

A paper by Simon Willcox et al was published in Cancer Causes and Control.

Simon worked on this project for his MPH Honours Thesis at USyd (Supervisors: Freddy Sitas and Bernie Steward). He obtained his MPH ‘with honours’.

This is the first formal analysis of the CLEAR study data illustrating the advantage of analysing a large sample size.  The results are interesting regarding what people think, and how that sometimes differs from what scientists think (some concordance, some discordance).

Click here to read the abstract of the paper.

Cancer Council NSW Biobank – A rich resource for researchers

Stability Study

CLEAR Study Materials

The NSW CLEAR Study collects information from men and women with all cancer types, and their cancer free partners. You can view the Male and Female Questionnaires, as well as the Participant Information Sheet, below.

Male Consent Form/Questionnaire

Female Consent Form/Questionnaire

Information Sheet for Participants

These materials are for your reference only. If you would like to be involved in recruitment for the CLEAR Study, please contact the study team.

Opportunities for and Obligations of the Collaborators:

Opportunities

• Collaborators will receive acknowledgment in publications, as defined in the document Publications Arising from CLEAR Study Data and Publications.
• Cancer Council will provide collaborators access to CLEAR Study data and biological samples on a preferential basis, provided those projects meet the approval of the Expert Advisory Comittee (EAC).
• Cancer Council will provide collaborators with access to statistical resources for approved studies on a preferential basis
• Collaborators will have the opportunity to nominate particular areas of research interest and will be invited to participate in any analyses conducted in these areas
• Cancer Council will provide assistance with the preparation of applications for external grant funding to use CLEAR data in studies approved by the EAC

Obligations

An investigator defined as a Collaborator in The CLEAR Study will, for the benefit of the Study:

• Recruit a minimum number of study participants eligible for the Study.  This number to be negotiated on a case by case basis, and determined by cancer type and size of hospital site, but should be not less than 100 patients and 100 controls
• Be Site Principal Investigator at an active clinical site which has site specific ethical approval
• Provide introduction to other clinicians at that site, and actively encourage and facilitate their participation in the Study
• Provide an annual progress report for each recruitment site.

Publications Arising from CLEAR Study Data and Biological Samples

Publications arising from the analysis of the CLEAR Study data or the CLEAR Study biological material will be the joint responsibility of Cancer Council NSW, the CLEAR Study investigators and, on a case by case basis, specified collaborators.

Collaborators will ensure the timely exchange of draft documents and dissemination of research findings. For multi-authored papers, a reasonable review period will be designated, and after that date, if comments are not received, approval will be deemed to be granted

No publications or presentations will be made by any collaborator without the express permission of the Expert Advisory Committee.

In the case where analyses have been led by a collaborator outside the CLEAR Study Investigator team, the following principles will apply:

• A study investigator must have been involved in the analysis
• A draft copy of any publication or report containing or based on data from the Data Set or on data from the biological samples (Publication) must be forwarded to the CLEAR Study Principal Investigator, at least 30 days prior to proposed submission, for technical review by the Expert Advisory Committee
• no publication of a Publication should occur if Expert Advisory Committee, in its discretion, notifies the Recipient that Expert Advisory Committee considers that the Publication uses inappropriate methodology to analyse the Data Set. If the Recipient has not received such notice from the Expert Advisory Committee within 30 days after providing the Publication to the Principal Investigator for review, the Recipient may submit it for publication
• The CLEAR Study is acknowledged in any Publication in the following format or such other format Cancer Council NSW requires:
  • The CLEAR Study is an initiative of Cancer Council NSW.  The CLEAR Study investigators are A Professor Freddy Sitas, Professor Dianne O’Connell, Dr Karen Canfell, Professor Michael Barton, Professor Emily Banks
  • All collaborators are to be acknowledged in a required format determined by the EAC
• a copy of any final Publication is forwarded to the CLEAR Study Principal Investigator and the Cancer Council NSW may choose to obtain an irrevocable, transferable, royalty-free licence (including the right to sub-license) from the relevant copyright owners to reproduce and adapt the Publication and communicate it to third parties

Authorship of the publications reporting the results will include the CLEAR Study investigator(s) as relevant, and collaborators and colleagues who make a substantive contribution and those who satisfy the criteria of the Vancouver / BMJ guidelines for the authorship of scientific manuscripts

Authorship order will be decided on a case-by-case basis but, in principle, authorship for papers should be negotiated in advance, particularly with regard to first, second, third, last and corresponding authors, although the order may be revised according to actual contribution as the manuscript is written.

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