Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130111
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-14
First Post:
2023-07-15
Brief Title:
Spatial Location of Breast Cancer Local Recurrence After Mastectomy
Sponsor:
Maastricht Radiation Oncology
Organization:
Maastricht Radiation Oncology
Study Overview
Official Title:
Spatial Location of Breast Cancer Local Recurrence After Mastectomy the Secret Study a Retrospective Analysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Secret
Brief Summary:
RationaleTo improve the definition of the target volume for radiotherapy of the chestwall after different types of mastectomy the exact localization of regions at risk for a local recurrence should be known However there are currently insufficient data in literature showing where local recurrences occur after different types of mastectomy
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 eg primary tumour bed scar skin subcutaneous nipple areola pectoral muscles
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 eg primary tumour bed scar skin subcutaneous nipple areola pectoral muscles
Detailed Description:
RationaleTo improve the definition of the target volume for radiotherapy of the chestwall after different types of mastectomy the exact localization of regions at risk for a local recurrence should be known However there are currently insufficient data in literature showing where local recurrences occur after different types of mastectomy
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 eg molecular subtypes lymphangiolymphovascular invasion and treatment-related factors eg 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 eg 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
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 eg molecular subtypes lymphangiolymphovascular invasion and treatment-related factors eg 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None