Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT01396993
Status:
UNKNOWN
Last Update Posted:
2015-09-23
First Post:
2011-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Non-randomized Evaluation of Oncoplastic Surgery
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
iTOP
Brief Summary:
Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has been demonstrated by several authors using restrospective analyses. However, no prospective observational trial has been done to objectively evaluate cosmetic and oncologic outcome comparing BCT with iTOP. The aim of this study is to investigate this issue within a prospective non randomized observational trial at the Medical University Vienna.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: