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Clinical Trial Summary

This PhD project will describe tumour characteristics and survival associated with of under- and overdiagnosed breast cancers, the rate of overdiagnosis in BreastScreen Norway, and whether women and family doctors are aware of, and knowledgeable about, under- and overdiagnosis in breast cancer screening.


Clinical Trial Description

Mammographic screening among women aged 50-69 reduces breast cancer mortality but also carries some risk. This PhD project will study under- and overdiagnosis, two risks associated with mammographic screening, in BreastScreen Norway. Underdiagnosis can occur when a tumour is present but not detected as a result of screening, while overdiagnosis can occur when a woman is diagnosed with a slow growing cancer that would not become symptomatic during her lifetime. This project will address the following topics and research questions using observational study methods. Study 1: To determine whether tumour histopathology and survival differentially associated with potentially under- or overdiagnosed interval and screen-detected breast cancers. - Do women with potentially underdiagnosed interval cancers have different tumour histopathology and survival than those whose interval cancers showed no signs at the prior screen? - Do women with potentially overdiagnosed screen-detected cancer have different tumour histopathology and survival than those whose screen-detected cancer showed no signs at the prior screen? Study 2: To estimate overdiagnosis in the screening program using individual-level data: - What was the rate of overdiagnosis for women screened in the program during 1996-2003? - How does adjusting for sociodemographic factors affect estimates of overdiagnosis? Study 3: To describe awareness and knowledge about under- and overdiagnosis and breast screening in general: - Are women aware of and knowledgeable about under- and overdiagnosis in breast screening? - Are family doctors aware of and knowledgeable about breast screening, and under- and overdiagnosis? Are they confident in their ability to relay this information to their patients? Study 1 is a quality improvement study and has approval from Personvernombudet (PVO 2016-4696). Study 2 has research ethics board (REK) approval (REK 2013/795), while REK approval will be sought for Study 3. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03852953
Study type Observational
Source Cancer Registry of Norway
Contact
Status Completed
Phase
Start date July 1, 2018
Completion date June 8, 2020

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