Progress update
4932 participants at 129 centres in 32 countries
Thank you to the dedicated teams at DCVAS sites
for this tremendous achievement.
Data entry is lagging behind recruitment with 4808 eligible participants registered in the database. Please aim to keep up to date with data completion. We are offering Amazon vouchers to the site that enters the 5000th eligible patient to the database and for the site with the highest percentage of locked data at 31/12/2015.
Study end date EXTENDED to 2017
DCVAS remains open to recruitment until December 2017 and all sites are welcome to continue recruiting to the study.
The study extension will allow us to
- Recruit to target in the comparator and TAK/PAN groups.
- Keep sub studies open under the current DCVAS ethical framework. This includes the collection of adult samples for the Paediatric Vasculitis Initiative (PedVas study).
- Our focus will be on the TAK/PAN/COMPARATOR groups. However, enrolment to all subgroups will continue.
Although recruitment will be ongoing, we plan to present results for the main subtypes at the ACR meeting in November 2016.
Eligibility widened to 5 years from diagnosis for TAK and PAN
Patients with a diagnosis of TAK or PAN can be consented up to 5 years from diagnosis. DCVAS SOP_002 has been revised as follows and is available on the WebLearn site.
Patients diagnosed with Takayasu arteritis or polyarteritis nodosa
Patients with a diagnosis of Takayasu arteritis or polyarteritis nodosa can be included if the diagnosis is no more than five years prior to the consent date. The investigator submitting the patient to the study must be reasonably satisfied that they have all relevant and correct clinical details. In addition, the following data must be available to support the diagnosis:
TAK: results from at least one imaging investigation.
PAN*: angiographic or vascular imaging results or histological evidence.
*NB: Patients with isolated skin vasculitis are excluded.
Remember we have approval to consent patients by telephone, if that is allowed within your local ethical approvals, in which case there would not be any need for a patient to attend clinic. The DCVAS SOP_010 outlines the procedure.
Data completion
NEW! We will be publishing the percentage of CRFs locked by each site on the website in July. Please check for participants overdue for follow up and/or CRFs which are incomplete.
- CRFs may only have one or two items outstanding before they can be locked.
- Many CRFs are 100% complete, but not yet locked.
It is important to review your data before locking.
- Go to the “review” tab and scroll down to ensure data are complete and accurate.
- Move to the “complete” tab and lock the data.
After locking, the coordinating site verifies the data and payment is made for each batch of 20 or more verified CRFs.
Please refer to the updated data quality guide. This will explain how study time points should be recorded. The guide also outlines the items we verify after data are locked. It is a good idea to check this as it will reduce queries back to your site.
Research proposals
We welcome proposals from contributors to the study. Prior to submission of a proposal, please refer to the list of current projects to check that your proposal does not conflict with any existing areas of research. Researchers are encouraged to contact DCVAS investigators via dcvas@ndorms.ox.ac.uk to discuss proposals informally prior to submission.
- List of current projects with link to full outlines of each proposal
- Guidance for Research Proposals
- Standard research proposal application form
Site acknowledgement
The DCVAS study continues to be a major international success. While enrolment and data collection continues, some data analysis is already ongoing as per ancillary studies that have been proposed and approved by the Steering Committee.
More information about the overall publication policies of DCVAS will be forthcoming but we wish to create a system now to acknowledge the hard work of everyone involved in the study in the publications that arise from DCVAS. To do this we need you to provide an accurate list of all investigators and research staff who have had substantive involvement with the collection of data for DCVAS. These names will be listed in an appendix and/or as “collaborators” in the study; the “collaborator” status means the names appear and are searchable in Medline/PubMed.
If you have not returned your form, please do so as soon as possible or request further information from dcvas@ndorms.ox.ac.uk
DCVAS Collaborations – Sites needed for sub study
PEDIATRIC VASCULITIS INITIATIVE (PEDVAS)
DCVAS SITES NEEDED FOR ADULT SAMPLES
The PedVas study, coordinated by the University of British Columbia (UBC) and funded by the Canadian Institutes of Health Research will characterise paediatric vasculitis and undertake biomarker discovery over the next 5 years.
The main aims of the study are:
- To improve classification of childhood vasculitis
- Improve clinical tools to assess disease activity
- To explore genetic and RNA signatures to aid classification and severity of vasculitis
Clinical data and samples collected from adults in DCVAS will be compared with parallel childhood data:
- DCVAS patients consent to collection and storage of biological samples on Part B of the DCVAS consent form.
- Samples are taken from two cohorts.
- Cohort 1 – patients with vasculitis (excepting GCA) who have not been treated with immunosuppressants for more than7 days (RNA, DNA and plasma).
- Cohort 2 – All other patients with vasculitis (DNA sample)
- Sample acquisition form documenting medications and DCVAS CRF is completed on-line.
- Payment is made for samples and all consumables and shipping costs to UBC are provided.
Please contact Anthea Craven or Marian Montgomery if you wish to take part.
DCVAS is sponsored by the University of Oxford
DCVAS STUDY OFFICE DCVAS@ndorms.ox.ac.uk
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
Nuffield Orthopaedic Centre, Oxford, OX3 7HE
DCVAS is funded by
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