NCT03165006

Brief Summary

This is a multicenter retrospective cohort of women participating in breast cancer screening programs in Spain between 2000 and 2009, with a cancer diagnosed during the screening or between the screening interval (interval cancer), specifically true interval cancers and false negatives. The investigators obtained woman-related information (including breast density), tumor-related information (including tumor phenotype), and follow-up information (including relapses, second neoplasms and vital status at the end of follow up (June 2014)). The objective is to evaluate the survival and disease-free period of women participating in screening programs for breast cancer with a cancer diagnosed during the screening or an interval cancer, specifically true interval cancers and false negatives. This study is part of a broader project (CAMISS study), which also includes one prospective cohort (CAMISS Prospective cohort - Identifier in ClinicalTrials.gov: NCT02439554).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,086

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

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

January 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

May 18, 2017

Last Update Submit

May 22, 2017

Conditions

Breast Cancer

Keywords

Breast cancer, screening, survival

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Death from any cause

    From date of cancer diagnosis until the date of death from any cause, assessed up to 14 years

Secondary Outcomes (3)

  • Recurrences and second breast neoplasms

    From date of cancer diagnosis until the date of the first recurrence or second breast neoplasm, whichever came first, assessed up to 14 years

  • Treatment-related complications

    From the date of surgery until the end of follow-up, assessed up to 14 years.

  • Readmissions to hospital for reasons related to breast cancer

    From the date of surgery until the end of follow-up, assessed up to 14 years.

Study Arms (1)

Screened women with breast cancer

Procedure: Mode of detection: Cancer detected at screeningProcedure: Mode of detection: Interval cancer

Interventions

Mode of detection: Cancer detected at screeningPROCEDURE

Cancers detected as a result of screening mammograms.

Screened women with breast cancer
Mode of detection: Interval cancerPROCEDURE

Cancers diagnosed after a negative screening mammogram and before the next screening invitation (2 years in Spain)

Screened women with breast cancer

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen participating at screening
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women screened for breast cancer and diagnosed for breast cancer in the screening program (screen-detected cancer) or within the interval between 2 screening rounds (interval cancer)

You may qualify if:

  • Women aged between 50 to 69 years with invasive or in situ breast cancer.

You may not qualify if:

  • Women diagnosed with lobular carcinoma in situ.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Romero A, Tora-Rocamora I, Bare M, Barata T, Domingo L, Ferrer J, Tora N, Comas M, Merenciano C, Macia F, Castells X, Sala M; CAMISS Study Group. Prevalence of persistent pain after breast cancer treatment by detection mode among participants in population-based screening programs. BMC Cancer. 2016 Sep 15;16(1):735. doi: 10.1186/s12885-016-2768-1.

    PMID: 27632982RESULT

  • Miret C, Domingo L, Louro J, Barata T, Bare M, Ferrer J, Carmona-Garcia MC, Castells X, Sala M. Factors associated with readmissions in women participating in screening programs and treated for breast cancer: a retrospective cohort study. BMC Health Serv Res. 2019 Dec 5;19(1):940. doi: 10.1186/s12913-019-4789-3.

    PMID: 31805926DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 24, 2017

Study Start

January 1, 2013

Primary Completion

June 30, 2014

Study Completion

December 31, 2015

Last Updated

May 24, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share