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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165006
• Other study ID #: CAMISS study
• Status: Completed
• Phase: N/A
• First received: May 18, 2017
• Last updated: May 22, 2017
• Start date: January 1, 2013
• Est. completion date: December 31, 2015

Study information

• Verified date: May 2017
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1086
• Est. completion date: December 31, 2015
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Mode of detection: Cancer detected at screening
Cancers detected as a result of screening mammograms.
• Mode of detection: Interval cancer
Cancers diagnosed after a negative screening mammogram and before the next screening invitation (2 years in Spain)

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Parc de Salut Mar	European Regional Development Fund, Fondo de Investigacion Sanitaria, Red de Investigación en Servicios de Salud y Enfermedades Crónicas (REDISSEC)

References & Publications (1)

Romero A, Torà-Rocamora I, Baré M, Barata T, Domingo L, Ferrer J, Torà N, Comas M, Merenciano C, Macià F, Castells X, Sala M; CAMISS Study Group.. Prevalence of persistent pain after breast cancer treatment by detection mode among participants in populati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death from any cause	From date of cancer diagnosis until the date of death from any cause, assessed up to 14 years
Secondary	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
Secondary	Treatment-related complications		From the date of surgery until the end of follow-up, assessed up to 14 years.
Secondary	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.

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