NCT03852953

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,915

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2020

Completed
Last Updated

August 28, 2024

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

November 12, 2018

Last Update Submit

August 26, 2024

Conditions

Breast Cancer

Keywords

ScreeningMammographyOverdiagnosisWomens' perspectivesHarms and benefitsFalse negativeQuantitative methodsSurvival

Outcome Measures

Primary Outcomes (8)

  • Study 1: Prognostic and predictive histopathologic characteristics

    \- Histopathological type (Ductal carcinoma in situ, invasive carcinoma of no special type, invasive lobular carcinoma)

    At time of diagnosis

  • Study 1: Prognostic and predictive histopathologic characteristics

    \- Maximum tumour diameter (mm)

    At time of diagnosis

  • Study 1: Prognostic and predictive histopathologic characteristics

    \- Tumour grade (1, 2, 3)

    At time of diagnosis

  • Study 1: Prognostic and predictive histopathologic characteristics

    \- Lymph node involvement (Yes/No)

    At time of diagnosis

  • Study 1: Prognostic and predictive histopathologic characteristics

    \- Receptor status (Positive/Negative)

    At time of diagnosis

  • Study 1: Prognostic and predictive histopathologic characteristics

    \- Ki67 expression (0-100%)

    At time of diagnosis

  • Study 2: Crude and adjusted rate of overdiagnosis

    \- Crude and adjusted measures of overdiagnosis will be presented to show the amount and direction of confounding resulting from sociodemographic factors.

    1996 to 2016

  • Study 3: Agreement between awareness and knowledge of overdiagnosis

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

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

Secondary Outcomes (2)

  • Study 1: Survival

    Date of diagnosis until 31 December 2017

  • Study 1: Survival

    Date of diagnosis until 31 December 2017

Other Outcomes (2)

  • Study 3: Factors associated with awareness and knowledge of overdiagnosis

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

  • Study 3: Factors associated with awareness and knowledge of overdiagnosis

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

Study Arms (3)

Study 1: Under- and overdiagnosed group

Non-proportional stratified sample of women diagnosed with interval or screen-detected breast cancers after participation in BreastScreen Norway. This sample will include under- or overdiagnosed cancers, as well as cancers that were not under- or overdiagnosed.

Other: Under- or overdiagnosed cancer

Study 2: Rate of overdiagnosis group

Women residing in Norway, born between 1927 and 1934 (inclusive). This cohort will include women who have attended screening and who have not attended screening.

Other: Screening

Study 3: Awareness and knowledge group

Women aged 50-69, and practising family doctors aged 25-75, currently living in Norway.

Interventions

Under- or overdiagnosed cancerOTHER

Diagnosed with a cancer that was visible on prior mammograms

Study 1: Under- and overdiagnosed group
ScreeningOTHER

Invited or attended BreastScreen Norway

Study 2: Rate of overdiagnosis group

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women aged 50-69, and practising female and male family doctors aged 25-75, residing in Norway.

You may qualify if:

  • Breast cancer diagnosed within BreastScreen Norway using digital mammography
  • Prior screening images available for review
  • Study 2
  • Women born between 1927 and 1934 (inclusive)
  • Legal resident in Norway at any time between 1996 and 2003 (inclusive)
  • Study 3
  • Women residing in Norway, aged 50-69 (inclusive)
  • Practising family doctors in Norway, aged 25-75 (inclusive)
  • Provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Registry of Norway

Oslo, 0379, Norway

Location

Related Publications (3)

  • Hovda T, Tsuruda K, Hoff SR, Sahlberg KK, Hofvind S. Radiological review of prior screening mammograms of screen-detected breast cancer. Eur Radiol. 2021 Apr;31(4):2568-2579. doi: 10.1007/s00330-020-07130-y. Epub 2020 Oct 1.

    PMID: 33001307BACKGROUND

  • Tsuruda KM, Hovda T, Bhargava S, Veierod MB, Hofvind S. Survival among women diagnosed with screen-detected or interval breast cancer classified as true, minimal signs, or missed through an informed radiological review. Eur Radiol. 2021 May;31(5):2677-2686. doi: 10.1007/s00330-020-07340-4. Epub 2020 Nov 12.

    PMID: 33180162RESULT

  • Tsuruda KM. Overdiagnosis and 'underdiagnosis' in BreastScreen Norway [dissertation]. [Oslo, Norway]: University of Oslo; 2021. 108 p. Available at: http://urn.nb.no/URN:NBN:no-91337

    RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Solveig Hofvind, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2018

First Posted

February 25, 2019

Study Start

July 1, 2018

Primary Completion

June 8, 2020

Study Completion

June 8, 2020

Last Updated

August 28, 2024

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)