Southeast Netherlands Advanced Metastatic Breast Cancer Registry
NCT03577197
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- Diagnosed with de novo or recurrent advanced breast cancer in 2007-2019
- Diagnosed with or treated for advanced breast cancer in one of the participating hospitals
- Participating hospitals (period of inclusion): Maastricht UMC+ (2007-2019), Zuyderland hospitals Sittard/Heerlen (2007-2019), Amphia Hospital Breda (2007-2019), Catharina Hospital Eindhoven (2007-2019), Elkerliek Hospital Helmond (2007-2019), Maxima Medical Center Veldhoven/Eindhoven (2010-2019), Jeroen Bosch Hospital Den Bosch (2007-2019), Laurentius Hospital Roermond (2007-2019), St. Annaziekenhuis Geldrop (2007-2019), St. Elisabeth Hospital Tilburg (2007-2009), St. Jans Gasthuis Weert (2007-2019), VieCuri Medical Center Venlo/Venray (2007-2014), all in the Netherlands.
- Hospitals (and periods) were eligible for inclusion if (distant) registration from Maastricht UMC+ was possible.
- Other hospitals will be added during the running phase of the study, and possibly the inclusion period may be prolonged after 2020.
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Descriptive Information | |||||||||
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Brief Title | Southeast Netherlands Advanced Metastatic Breast Cancer Registry | ||||||||
Official Title | Southeast Netherlands Advanced Breast Cancer Registry | ||||||||
Brief Summary | The Southeast Netherlands Advanced Breast Cancer (SONABRE) Registry is a real life multi-center study. The registry aims to include all patients diagnosed with advanced breast cancer as of 2007 in 14 hospitals in the Netherlands. Data on patient, tumor and treatment characteristics are collected retrospectively from electronic medical files by trained registry clerks. | ||||||||
Detailed Description | This SONABRE registry is an ongoing observational cohort study aiming at the inclusion of all patients aged ?18 years and diagnosed with advanced breast cancer in 2007-2019 in 14 hospitals in the Southeast of the Netherlands. Patients with de novo or recurrent advanced breast cancer were identified from the hospital-based management information systems. Specially trained registration clerks retrospectively collected data from the medical files of the patients based on extensive medical chart review. Information was collected about patient and tumour characteristics, type of treatment (surgery, radiotherapy and systemic treatment, both neo-adjuvant, adjuvant and palliative), palliative treatment changes due to adverse events, hospitalization, comorbidities and outcomes (progression and death). The SONABRE Registry has already been effectively used to perform real-life studies on safety and (cost-)effectiveness of various systemic treatments used in patients diagnosed with advanced breast cancer. | ||||||||
Study Type | Observational [Patient Registry] | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||||||
Target Follow-Up Duration | 1 Year | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Probability Sample | ||||||||
Study Population | All consecutive patient diagnosed with advanced breast cancer between 2007-2019 in 14 hospitals in the Netherlands. No patients are being excluded. Also patients with no systemic / active antitumor therapy for advanced breast cancer will be included. The SONABRE Registry includes 14 hospitals: 1 academic, 7 teaching and 6 general hospitals. The Netherlands counts 114 hospitals, including 8 academic, 25 teaching, 58 general and 23 categorical hospitals. | ||||||||
Condition |
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Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Not Provided | ||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment | 5000 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 31, 2020 | ||||||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: none | ||||||||
Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Netherlands | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03577197 | ||||||||
Other Study ID Numbers | MUMC-MO-2015-01 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | V.C.G. Tjan-Heijnen, Academisch Ziekenhuis Maastricht | ||||||||
Study Sponsor | Academisch Ziekenhuis Maastricht | ||||||||
Collaborators |
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Investigators | Not Provided | ||||||||
PRS Account | Academisch Ziekenhuis Maastricht | ||||||||
Verification Date | November 2019 |