Spatial Location of Breast Cancer Local Recurrence After Mastectomy
NCT ID: NCT06130111
Last Updated: 2023-11-14
Study Results
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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ACTIVE_NOT_RECRUITING
170 participants
OBSERVATIONAL
2021-09-01
2024-01-01
Brief Summary
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Objective: The primary objective of the proposed study is to determine whether the spatial, location of a breast cancer recurrence after mastectomy, differs for different types of mastectomy.
Study design: Retrospective study evaluating spatial location and site of recurrences after mastectomy.
Study population: The investigators aim to include all breast cancer patients treated with mastectomy in the Netherlands between 2003- 2008, and known to have experienced a local recurrence as the first site of failure.
Primary endpoint: Spatial location of local recurrence (e.g., primary tumour bed, scar, skin, subcutaneous, nipple, areola, pectoral muscles).
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Detailed Description
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Objective: The primary objective of the proposed study is to determine whether the spatial, location of a breast cancer recurrence after mastectomy, differs for different types of mastectomy. Secondary objectives are to assess whether tumour characteristics (e.g., molecular subtypes, lymphangio/lymphovascular invasion) and treatment-related factors (e.g., PMRTwith or without bolus, radiation volumes, doses) influence the site of recurrence and spatial location.
Study design: Retrospective study evaluating spatial location and site of recurrences after mastectomy.
Study population: The investigators aim to include all breast cancer patients treated with mastectomy in the Netherlands between 2003- 2008, and known to have experienced a local recurrence as the first site of failure.
Primary endpoint: Primary endpoint: Spatial location of local recurrence (e.g., primary tumour bed, scar, skin, subcutaneous, nipple, areola, pectoral muscles).
Other study parameters: First descriptive statistics will be performed to investigate whether there is a relation between the localization of the recurrence and the type of mastectomy: modified radical mastectomy (MRM), skin-sparing mastectomy (SSM), nipple sparing mastectomy (NSM).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Mastectomy
Mastectomy as a surgical procedure for breast cancer (regardless of perioperative treatment).
Eligibility Criteria
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Inclusion Criteria
* Proven histology of first invasive breast cancer
* Mastectomy as a surgical procedure for breast cancer (regardless of perioperative treatment).
* Having a local recurrence, as primary event
* reast cancer diagnosis in the period 2003-2008.
Exclusion Criteria
* Primary metastatic breast cancer.
* Mastectomy for breast cancer recurrence after earlier breast conserving therapy.
* Synchronous breast cancer.
18 Years
FEMALE
No
Sponsors
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Albert Schweitzer Hospital
OTHER
Canisius-Wilhelmina Hospital
OTHER
Diakonessenhuis, Utrecht
OTHER
Erasmus Medical Center
OTHER
Franciscus Gasthuis
OTHER
Haaglanden Medical Centre
OTHER
Jeroen Bosch Ziekenhuis
OTHER
Maastricht University Medical Center
OTHER
Maxima Medical Center
OTHER
St. Antonius Hospital
OTHER
Laurentius ziekenhuis
UNKNOWN
VieCuri Medical Centre
OTHER
NKI-AvL
UNKNOWN
Ziekenhuis Netwerk Antwerpen (ZNA)
OTHER
Aarhus University Hospital
OTHER
Sheba Medical Center
OTHER_GOV
University of Florence
OTHER
Maastricht Radiation Oncology
OTHER
Responsible Party
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Principal Investigators
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Liesbeth Boersma, Prof.
Role: PRINCIPAL_INVESTIGATOR
Maastro
Locations
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Maastro
Maastricht, Limburg, Netherlands
Countries
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Other Identifiers
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W 21 04 00088
Identifier Type: -
Identifier Source: org_study_id
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