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Completed

NCT Number: NCT03852953

Under- and Overdiagnosis in BreastScreen Norway

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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Registry of Norway

Oslo, 0379, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Study 1

Inclusion criteria

  • Breast cancer diagnosed within BreastScreen Norway using digital mammography
  • Prior screening images available for review

Study 2

Inclusion criteria

  • Women born between 1927 and 1934 (inclusive)
  • Legal resident in Norway at any time between 1996 and 2003 (inclusive)

Study 3

Inclusion criteria

  • Women residing in Norway, aged 50-69 (inclusive)
  • Practising family doctors in Norway, aged 25-75 (inclusive)
  • Provide informed consent

Treatment and study plan

Under- or overdiagnosed cancer

Other

Diagnosed with a cancer that was visible on prior mammograms

Screening

Other

Invited or attended BreastScreen Norway

Primary outcomes

  1. Study 1: Prognostic and predictive histopathologic characteristics

    Time frame: At time of diagnosis

    • Histopathological type (Ductal carcinoma in situ, invasive carcinoma of no special type, invasive lobular carcinoma)
  2. Study 1: Prognostic and predictive histopathologic characteristics

    Time frame: At time of diagnosis

    • Maximum tumour diameter (mm)
  3. Study 1: Prognostic and predictive histopathologic characteristics

    Time frame: At time of diagnosis

    • Tumour grade (1, 2, 3)
  4. Study 1: Prognostic and predictive histopathologic characteristics

    Time frame: At time of diagnosis

    • Lymph node involvement (Yes/No)
  5. Study 1: Prognostic and predictive histopathologic characteristics

    Time frame: At time of diagnosis

    • Receptor status (Positive/Negative)
  6. Study 1: Prognostic and predictive histopathologic characteristics

    Time frame: At time of diagnosis

    • Ki67 expression (0-100%)
  7. Study 2: Crude and adjusted rate of overdiagnosis

    Time frame: 1996 to 2016

    • Crude and adjusted measures of overdiagnosis will be presented to show the amount and direction of confounding resulting from sociodemographic factors.
  8. Study 3: Agreement between awareness and knowledge of overdiagnosis

    Time frame: One day (Measurements taken once at time of survey completion)

    Agreement between awareness (yes versus no/incomplete) and knowledge (yes versus no/incomplete) of overdiagnosis

Secondary outcomes

  1. Study 1: Survival

    Time frame: Date of diagnosis until 31 December 2017

    • Overall survival
  2. Study 1: Survival

    Time frame: Date of diagnosis until 31 December 2017

    • Breast cancer specific survival

Other outcomes

  1. Study 3: Factors associated with awareness and knowledge of overdiagnosis

    Time frame: One day (Measurements taken once at time of survey completion)

    Using a self-administered web-based questionnaire designed for this study, the investigators will analyse survey responses to determine whether self-reported age (categorised into 5-year age groups) is associated with awareness and knowledge of overdiagnosis. This will be done separately for women and family doctors.

  2. Study 3: Factors associated with awareness and knowledge of overdiagnosis

    Time frame: One day (Measurements taken once at time of survey completion)

    Using a self-administered web-based questionnaire designed for this study, the investigators will analyse survey responses to determine whether self-reported formal education (none; primary school; high school; up to 4 years postsecondary; more than 4 years of postsecondary education) is associated with awareness and knowledge of overdiagnosis among women.

Sponsors and collaborators

Lead sponsor

Norwegian Institute of Public Health

Other Gov

Collaborators

  • Extrastiftelsen

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 25, 2019
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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