Effect of Interval Cancer and Screening Process on Survival and Disease-free Period in Breast Cancer

NCT ID: NCT03165006

Last Updated: 2017-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1086 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2015-12-31

Brief Summary

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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).

Detailed Description

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The general objective for this study 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.

The cohort has information of women participating in breast cancer screening programs in Spain between 2000 and 2009, with a breast 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)).

Expected results: Nowadays there are no results of cohort analysis of the diagnostic process of care that integrates all those different aspects. This study will complement the evaluation of population screening, specifically the interval cancer and the impact on survival and disease-free period taking into account relevant variables like breast density, tumor phenotype, clinical complications, readmissions, and the surgical approach.

This study is part of a broader project (CAMISS study) coordinated by the Evaluation of Health Services of Epidemiology and Public Health Group, which consists of two cohorts of women diagnosed with breast cancer: a prospective cohort (n=2,040 incident cases of breast cancer diagnosed in 18 hospitals of 5 Spanish regions) (Identifier in ClinicalTrials.gov: NCT02439554) and a retrospective cohort of screened women diagnosed with breast cancer between 2000 and 2009 in two Spanish regions (n=1,086).

The general objective of the CAMISS study is to evaluate different aspects of health care received by patients with breast cancer like the diagnostic process, treatment, complications, survival, costs and quality of life to provide information to improve the effectiveness and cost-effectiveness of interventions, reduce variability, have better predictive rules and increase the quality of life.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Screened women with breast cancer

Mode of detection: Cancer detected at screening

Intervention Type PROCEDURE

Cancers detected as a result of screening mammograms.

Mode of detection: Interval cancer

Intervention Type PROCEDURE

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

Interventions

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Mode of detection: Cancer detected at screening

Cancers detected as a result of screening mammograms.

Intervention Type PROCEDURE

Mode of detection: Interval cancer

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Women diagnosed with lobular carcinoma in situ.
Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondo de Investigacion Sanitaria

OTHER

Sponsor Role collaborator

European Regional Development Fund

OTHER

Sponsor Role collaborator

Red de Investigación en Servicios de Salud en Enfermedades Crónicas

OTHER

Sponsor Role collaborator

Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Maria Sala

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 27632982 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31805926 (View on PubMed)

Related Links

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Other Identifiers

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CAMISS study

Identifier Type: -

Identifier Source: org_study_id

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