Participate in the unPAD study!
Interested in participation? Please download the protocol and METC info, and send an email to L.M.A.Janssen_1@uvt.nl.
Summary of the unPAD study
aug 2016 | in The unPAD study
Objective: The primary objective of the unPAD study is to characterise ‘unclassified antibody deficiency’, for this project including ‘deficiency of specific IgG (specific antibody deficiency - SPAD)’, ‘IgA with IgG subclass deficiency’, ‘isolated IgG subclass deficiency’, ‘selective IgM deficiency’ and ‘selective IgA deficiency’ [the combined group is hereafter referred to as ‘unPAD patients’]. To this end, a set of research questions for the level 2/3 form were formulated by the antibody deficiency expert panel of the ESID Registry Working Party.
Study design: Observational cohort study using the ESID online Registry.
Protocol and METC of the unPAD study
You can download the protocol and METC info here.
In/exclusion criteria of the unPAD study
In order to be eligible to participate in the unPAD study, a subject must meet all of the following criteria:
- Informed consent for participation in the ESID Registry.
- Fulfill the ESID Registry Clinical Criteria for ‘unclassified antibody deficiency’, ‘deficiency of specific IgG (specific antibody deficiency - SPAD)’, ‘IgA with IgG subclass deficiency’, ‘isolated IgG subclass deficiency’, ‘selective IgM deficiency’ and/or ‘selective IgA deficiency’ (together: unPAD patients) or CVID (the control group) (see ESID website).
A potential subject who meets any of the following criteria will be excluded from participation in the unPAD study:
Refusal of the reporting physician to have all data that were entered in the ESID Registry by the centre checked and – if necessary – corrected under supervision of the unPAD study monitor(s).
The unPAD study is financially supported by Shire, PPTA and the Peribosch Foundation.