Lessons Learned from Setting Up a Prospective, Longitudinal, Multicenter Study with Women at High Risk for Breast Cancer

Cancer Epidemiology Biomarkers & Prevention, vol. 30, pp. 441–449

Abstract

Abstract Women identified with an increased risk of breast cancer due to mutations in cancer susceptibility genes or a familial history of breast cancer undergo tailored screening with the goal of detecting tumors earlier, when potential curative interventions are still possible. Ideally, screening would identify signs of carcinogenesis even before a tumor is detectable by imaging. This could be achieved by timely signaling of altered biomarker levels for precancerous processes in liquid biopsies. Currently, the Nipple Aspirate Fluid (NAF) and the Trial Early Serum Test BREAST cancer (TESTBREAST), both ongoing, prospective, multicenter studies, are investigating biomarkers in liquid biopsies to improve breast cancer screening in high-risk women. The NAF study focuses on changes over time in miRNA expression levels both in blood and NAF samples, whereas the TESTBREAST study analyzes changes in protein levels in blood samples at sequential interval timepoints. These within-subject changes are studied in relation to later occurrence of breast cancer using a nested case–control design. These longitudinal studies face their own challenges in execution, such as hindrances in logistics and in sample processing that were difficult to anticipate. This article offers insight into those challenges and concurrently aims to provide useful strategies for the set-up of similar studies. See related commentary by Sauter, p. 429

Authors 9

1. Susana I. S. Patuleia

   Utrecht University · University Medical Center Utrecht

   Affiliation as printed

   1Department of Pathology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands

   2Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands

2. Sophie C. Hagenaars Aachen

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   3Department of Surgery, Leiden University Medical Center, Leiden University, Leiden, the Netherlands

3. Cathy Beatrice Moelans

   Utrecht University · University Medical Center Utrecht

   Affiliation as printed

   1Department of Pathology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands

4. Margreet G.E.M. Ausems

   Utrecht University · University Medical Center Utrecht

   Affiliation as printed

   4Department of Genetics, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands

5. Carla Henrica van Gils

   Utrecht University · University Medical Center Utrecht

   Affiliation as printed

   5Department of Epidemiology of the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands

6. Rob A.�E.�M. Tollenaar Aachen

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   3Department of Surgery, Leiden University Medical Center, Leiden University, Leiden, the Netherlands

7. P. J. van Diest

   Utrecht University · University Medical Center Utrecht

   Affiliation as printed

   1Department of Pathology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands

8. Wilma E. Mesker Aachen

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   3Department of Surgery, Leiden University Medical Center, Leiden University, Leiden, the Netherlands

9. Elsken van der Wall corresponding

   Utrecht University · University Medical Center Utrecht

   Affiliation as printed

   2Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands