Effect of Interval Cancer and Screening Process on Survival and Disease-free Period in Breast Cancer
CAMISS Retrospective Cohort - Effect of Interval Cancer and Screening Process on Survival and Disease-free Period in Breast Cancer
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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Retrospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Screened women with breast cancer
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Cancers detected as a result of screening mammograms.
Cancers diagnosed after a negative screening mammogram and before the next screening invitation (2 years in Spain)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mortality
Lasso di tempo: From date of cancer diagnosis until the date of death from any cause, assessed up to 14 years
|
Death from any cause
|
From date of cancer diagnosis until the date of death from any cause, assessed up to 14 years
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Recurrences and second breast neoplasms
Lasso di tempo: From date of cancer diagnosis until the date of the first recurrence or second breast neoplasm, whichever came first, assessed up to 14 years
|
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
Lasso di tempo: From the date of surgery until the end of follow-up, assessed up to 14 years.
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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
Lasso di tempo: From the date of surgery until the end of follow-up, assessed up to 14 years.
|
From the date of surgery until the end of follow-up, assessed up to 14 years.
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
Collegamenti utili
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CAMISS study
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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