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Adjuvant VACcination against HPV in surgical treatment of Cervical Intra-epithelial Neoplasia (VACCIN study) a study protocol for a randomised controlled trial

Crossref DOI link: https://doi.org/10.1186/s12885-020-07025-7

Published Online: 2020-06-09

Published Print: 2020-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

van de Laar, R. L. O.

Hofhuis, W.

Duijnhoven, R. G.

Polinder, S.

Melchers, W. J. G.

van Kemenade, F. J.

Bekkers, R. L. M.

Van Beekhuizen, H. J.
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Article History

Received: 14 April 2020

Accepted: 1 June 2020

First Online: 9 June 2020

Ethics approval and consent to participate

: The study will be carried out according to the standards outlined in the Declaration of Helsinki. The medical ethical committee of the Erasmus Medical Centre has approved the study protocol (version 2.0; 21 March 2019, NL 66775.078.18). Prior to registration written informed consent will be obtained in all patients. Randomization happens after signing of the Informed Consent. All data will be anonymously processed. Participants will be able to resign at any time without statement of reasons.Patients from the following Dutch hospitals may be included: Amphia (Breda), Bernhoven (Uden) Catharina hospital (Eindhoven), Deventer Hospital (Deventer), Diakonessenhuis (Utrecht), Dijklander Hospital (Hoorn), Erasmus MC (Rotterdam), Flevo Hospital (Almere), Franciscus Gasthuis (Rotterdam), Gelre Hospital (Apeldoorn), Gelre Hospital (Zutphen), IJsselland Hospital (Rotterdam), Isala klinieken (Zwolle), Jeroen Bosch (Den Bosch), LUMC (Leiden), Reinier de Graaf Groep (Delft), VieCurie MC (Venlo), Zuyderland MC (Heerlen).

: Not applicable.

: F.J. Van Kemenade is an Editorial Board member for the journal. The other authors declare that they have no competing interests.

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