Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management. A Multicenter Observational Retrospective Study.

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Biological, Radiation
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Istituto Oncologico Veneto IRCCS
RECRUITING
Padua
Contact Information
Primary
Massimo Ferrucci, MD PhD
massimoferrucci@gmail.com
00393331779209
Backup
Daniele Passeri, MD
daniele.passeri.1995@gmail.com
00393333839397
Time Frame
Start Date: 2023-10-15
Estimated Completion Date: 2024-07-31
Participants
Target number of participants: 250
Treatments
Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast
Patients with diagnosis of pure pleomorphic lobular carcinoma in situ of the breast
Florid Lobular Carcinoma in Situ (FLCIS) of the breast
Patients with diagnosis of pure florid lobular carcinoma in situ of the breast
Related Therapeutic Areas
Sponsors
Leads: Istituto Oncologico Veneto IRCCS

This content was sourced from clinicaltrials.gov