Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133465
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-02
Brief Title:
Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast Towards an Increasingly Uniform Management
Sponsor:
Istituto Oncologico Veneto IRCCS
Organization:
Istituto Oncologico Veneto IRCCS
Study Overview
Official Title:
Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast Towards an Increasingly Uniform Management A Multicenter Observational Retrospective Study
Status:
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:
None
Brief Summary:
The goal of this retrospective multicenter observational study is to understand and evaluate the diagnostic and therapeutic management of pure forms of Florid Lobular Carcinoma In Situ FLCIS and Pleomorphic Lobular Carcinoma In Situ PLCIS of the breast It addresses the significant challenges and controversies surrounding their clinical management due to a lack of consensus or approved international guidelines
The main questions this study aims to answer are
How is the diagnostic process for pure FLCIS and PLCIS currently managed
What are the primary therapeutic approaches for these specific breast conditions
How are positive and close surgical excision margins handled
Is adjuvant treatment such as hormone therapy and radiotherapy necessary
What factors are associated with recurrences
What are the rates of recurrences andor upgrade to invasive carcinoma
Participants will retrospectively collect all cases of pure FLCIS and PLCIS reporting detailed data about their diagnostic and therapeutic management as well as clinical and survival outcomes
Methodology
This international multicenter retrospective study will collect cases involving the pure forms of FLCIS and PLCIS of the breast The study aims to provide insights into the current diagnostic and therapeutic approaches along with the identification of opportunities to enhance clinical management ultimately providing evidence-based recommendations and addressing the current lack of scientific literature regarding their treatment
The main questions this study aims to answer are
How is the diagnostic process for pure FLCIS and PLCIS currently managed
What are the primary therapeutic approaches for these specific breast conditions
How are positive and close surgical excision margins handled
Is adjuvant treatment such as hormone therapy and radiotherapy necessary
What factors are associated with recurrences
What are the rates of recurrences andor upgrade to invasive carcinoma
Participants will retrospectively collect all cases of pure FLCIS and PLCIS reporting detailed data about their diagnostic and therapeutic management as well as clinical and survival outcomes
Methodology
This international multicenter retrospective study will collect cases involving the pure forms of FLCIS and PLCIS of the breast The study aims to provide insights into the current diagnostic and therapeutic approaches along with the identification of opportunities to enhance clinical management ultimately providing evidence-based recommendations and addressing the current lack of scientific literature regarding their treatment
Detailed Description:
Classical lobular carcinoma in situ CLCIS of the breast is considered a non-obligate precursor of invasive carcinoma Histologically it is categorized as a lesion with uncertain malignancy potential and clinical management often parallels that of benign neoplastic conditions
In contrast its two variants florid LCIS FLCIS and pleomorphic LCIS PLCIS have distinct morphological and genetic characteristics and a higher probability of being obligatory precursors to invasive carcinoma
PLCIS shows marked cellular-nuclear pleomorphism resembling high-grade ductal carcinoma in situ often initially misdiagnosed as such
FLCIS on the other hand displays a complete architectural subversion of lobular structure due to the increased rate of cell replication
Both variants may show foci of comedonecrosis a distinctive but not specific diagnostic feature
A significant difference from CLCIS is their breast distribution CLCIS tends to be multifocal while the two variants typically present as unifocal
Genetically the two variants differ from CLCIS with higher genetic instability and increased alterations in genes coding for tumor suppressors and proteins involved in cell growth regulation and replication
Immunohistochemically both FLCIS and PLCIS regularly express estrogen and progesterone receptors and they may present higher HER2 Human Epidermal growth factor Receptor 2 - ERBB2 gene over-expression compared to CLCIS
Many controversies persist in the clinical management of these variants largely due to their rarity in pure isolated forms Often they are associated with an invasive carcinoma which becomes the primary therapeutic focus according to well established treatment protocols Dedicated studies both prospective and retrospective are completely lacking in the literature especially for pure FLCIS Consequently there is no consensus or approved international guidelines for accurate diagnostic-therapeutic strategies Even the histological categorization of biopsy tests still remains a subject of debate
Presently there is unanimous consensus on the indication for surgical excision of these lesions to improve histological definition and exclude the presence of an invasive neoplastic focus However there is no consensus on the need of surgical margins cavity shaving and the management of resection margins when they are proved to be close or involved at the final specimen pathological report Furthermore there is a lack of evidence-based recommendations for adjuvant therapies like radiotherapy or endocrine therapy Some scientific international associations such as ESMO European Society of Medical Oncology suggest a similar approach to pleomorphic variants as for ductal carcinoma in situ due to their morphological similarity yet in the absence of robust evidence this stance does not definitively support the benefit of adjuvant therapeutic strategies and poses a relative risk of overtreatment
To address these challenges the investigators propose international multicenter retrospective collection of cases involving the pure forms of FLCIS and PLCIS Our goal is to comprehensively analyze the diagnostic and therapeutic management of this specific patient group and notably to fill the gap in the scientific literature regarding their treatment
In contrast its two variants florid LCIS FLCIS and pleomorphic LCIS PLCIS have distinct morphological and genetic characteristics and a higher probability of being obligatory precursors to invasive carcinoma
PLCIS shows marked cellular-nuclear pleomorphism resembling high-grade ductal carcinoma in situ often initially misdiagnosed as such
FLCIS on the other hand displays a complete architectural subversion of lobular structure due to the increased rate of cell replication
Both variants may show foci of comedonecrosis a distinctive but not specific diagnostic feature
A significant difference from CLCIS is their breast distribution CLCIS tends to be multifocal while the two variants typically present as unifocal
Genetically the two variants differ from CLCIS with higher genetic instability and increased alterations in genes coding for tumor suppressors and proteins involved in cell growth regulation and replication
Immunohistochemically both FLCIS and PLCIS regularly express estrogen and progesterone receptors and they may present higher HER2 Human Epidermal growth factor Receptor 2 - ERBB2 gene over-expression compared to CLCIS
Many controversies persist in the clinical management of these variants largely due to their rarity in pure isolated forms Often they are associated with an invasive carcinoma which becomes the primary therapeutic focus according to well established treatment protocols Dedicated studies both prospective and retrospective are completely lacking in the literature especially for pure FLCIS Consequently there is no consensus or approved international guidelines for accurate diagnostic-therapeutic strategies Even the histological categorization of biopsy tests still remains a subject of debate
Presently there is unanimous consensus on the indication for surgical excision of these lesions to improve histological definition and exclude the presence of an invasive neoplastic focus However there is no consensus on the need of surgical margins cavity shaving and the management of resection margins when they are proved to be close or involved at the final specimen pathological report Furthermore there is a lack of evidence-based recommendations for adjuvant therapies like radiotherapy or endocrine therapy Some scientific international associations such as ESMO European Society of Medical Oncology suggest a similar approach to pleomorphic variants as for ductal carcinoma in situ due to their morphological similarity yet in the absence of robust evidence this stance does not definitively support the benefit of adjuvant therapeutic strategies and poses a relative risk of overtreatment
To address these challenges the investigators propose international multicenter retrospective collection of cases involving the pure forms of FLCIS and PLCIS Our goal is to comprehensively analyze the diagnostic and therapeutic management of this specific patient group and notably to fill the gap in the scientific literature regarding their treatment
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