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Cardiovascular, antidepressant and immunosuppressive drug use in relation to risk of cutaneous melanoma: a protocol for a prospective case–control study
  1. Leon Alexander Mclaren Berge1,
  2. Bettina Kulle Andreassen1,
  3. Jo Steinson Stenehjem1,2,
  4. Inger Kristin Larsen1,
  5. Kari Furu3,
  6. Asta Juzeniene4,
  7. Ingrid Roscher5,
  8. Trond Heir6,
  9. Adele Green7,
  10. Marit Bragelien Veierød2,
  11. Trude Eid Robsahm1
  1. 1 Department of Research, Kreftregisteret, Oslo, Norway
  2. 2 Department of Biostatistics, Universitetet i Oslo Institutt for medisinske basalfag, Oslo, Norway
  3. 3 Department of Pharmacoepidemiology, Nasjonalt folkehelseinstitutt, Oslo, Norway
  4. 4 Department of Radiation Biology, Oslo Universitetssykehus Institutt for kreftforskning, Oslo, Norway
  5. 5 Department of Rheumatology, Dermatology and Infectious Diseases, Oslo University Hospital, Oslo, Norway
  6. 6 Section for Trauma, Catastrophes and Forced Migration - Adults and Elderly, Nasjonalt kunnskapssenter om vold og traumatisk stress AS, Oslo, Norway
  7. 7 QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia
  1. Correspondence to Leon Alexander Mclaren Berge; Leon.Berge{at}kreftregisteret.no

Abstract

Introduction The incidence of cutaneous melanoma (hereafter melanoma) has increased dramatically among fair-skinned populations worldwide. In Norway, melanoma is the most rapidly growing type of cancer, with a 47% increase among women and 57% among men in 2000–2016. Intermittent ultraviolet exposure early in life and phenotypic characteristics like a fair complexion, freckles and nevi are established risk factors, yet the aetiology of melanoma is multifactorial. Certain prescription drugs may have carcinogenic side effects on the risk of melanoma. Some cardiovascular, antidepressant and immunosuppressive drugs can influence certain biological processes that modulate photosensitivity and immunoregulation. We aim to study whether these drugs are related to melanoma risk.

Methods and analysis A population-based matched case–control study will be conducted using nation-wide registry data. Cases will consist of all first primary, histologically verified melanoma cases diagnosed between 2007 and 2015 identified in the Cancer Registry of Norway (14 000 cases). Ten melanoma-free controls per case (on date of case melanoma diagnosis) will be matched based on sex and year of birth from the National Registry of Norway. For the period 2004—2015, and by using the unique personal identification numbers assigned to all Norwegian citizens, the case–control data set will be linked to the Norwegian Prescription Database for information on drugs dispensed prior to the melanoma diagnosis, and to the Medical Birth Registry of Norway for data regarding the number of child births. Conditional logistic regression will be used to estimate associations between drug use and melanoma risk, taking potential confounding factors into account.

Ethics and dissemination The project is approved by the Regional Committee for Medical Research Ethics in Norway and by the Norwegian Data Protection Authority. The study is funded by the Southeastern Norway Regional Health Authority. Results will be published in peer-reviewed journals and disseminated further through scientific conferences, news media and relevant patient interest groups.

  • cutaneous melanoma
  • prescription drugs
  • cardiovascular drugs
  • antidepressants
  • immunosuppressive
  • pharmacoepidemiology

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Patient consent for publication Not required.

  • Contributors TER conceived the study. TER, BKA, MBV and AJ contributed to the project design. LAMB and TER drafted the manuscript while BKA, MBV, JSS, IKL, KF, AJ, IR, TH and AG reviewed and revised it critically and approved the final version for submission. LAMB and TER are the guarantors.

  • Funding This research project was reviewed and has been granted funding by the South-Eastern Norway Regional Health Authority (no. 16/00451-33).

  • Competing interests None declared.

  • Ethics approval The research project has received ethical approval from the Regional Committee for Medical and Health Research Ethics (no 2017/1246) and approval from the Norwegian Data Protection Authority. The project is also approved by the NorPD, Cancer Registry of Norway and the MBRN.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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