Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management. A Multicenter Observational Retrospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Recurrence rate
研究概览
简要总结
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 and/or 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of PLCIS and/or FLCIS of the breast on both core-biopsy and/or on final specimen histology;
- •Aged 18 years or older.
排除标准
- •Histologic diagnosis of CLCIS;
- •Histologic diagnosis of LCIS (any type) associated with invasive carcinoma
结局指标
主要结局
Recurrence rate
时间窗: From date of surgery until the date of first documented recurrence, assessed up to 120 months
Recurrence rate (both invasive and LCIS, any type)
Upgrade rate to invasive carcinoma
时间窗: From date of diagnostic core biopsy until the date of final pathology report after surgery, assessed up to 6 months
Upgrade rate from PLCIS and/or FLCIS to invasive carcinoma from diagnostic core-biopsy to final specimen histology
次要结局
- Rate of adjuvant therapies utilization(From date of surgery until the date of adjuvant therapies completion, assessed up to 120 months)
- Postoperative complications(From date of surgery until any post-operative complications are resolved, assessed up to 3 months)
- Overall Survival (OS)(From date of surgery until the date of last follow-up or date of death from any cause, whichever came first, assessed up to 120 months)
- Disease-free survival (DFS)(From date of surgery until the date of first recurrence, whenever occurred, assessed up to 120 months)
- Rate of re-operation and/or radiotherapy boost and/or clinical follow-up after "close" or involved resection margins being reported(From date of surgery until the date of surgical margins management completion (any potential clinical follow-up included), assessed up to 72 months)
研究者
Ferrucci Massimo
Principal Investigator, MD PhD
Istituto Oncologico Veneto IRCCS