RBR-6n3crpc Involvement of the areola and nipple in women with Breast Cancer: what clinical exams, imaging, and surgical analysis re...

Date of registration: 08/25/2025 ^(mm/dd/yyyy)
Last approval date : 08/25/2025 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1327-4670

• Public title:

  en

  Involvement of the areola and nipple in women with Breast Cancer: what clinical exams, imaging, and surgical analysis reveal

  pt-br

  Comprometimento da aréola e mamilo em mulheres com Câncer de Mama: o que mostram os exames clínicos, de imagem e a análise da cirurgia

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 81565624.8.0000.0071
    Issuing authority: Plataforma Brasil
  • 7.312.465
    Issuing authority: Comitê de Ética em Pesquisa do Hospital Israelita Albert Eisntein

Sponsors

• Primary sponsor: Hospital Israelita Albert Einstein - São Paulo
• Secondary sponsor:
  • Institution: Hospital Israelita Albert Einstein - São Paulo
• Supporting source:
  • Institution: Hospital Israelita Albert Einstein - São Paulo

Health conditions

• Health conditions:

  en

  Breast Neoplasms

  pt-br

  Neoplasias da Mama

• General descriptors for health conditions:

  en

  E04.466 Mastectomy

  pt-br

  E04.466 Mastectomia

• Specific descriptors:

  en

  C04.588.180 Breast Neoplasms

  pt-br

  C04.588.180 Neoplasias da Mama

Interventions

• Interventions:

  en

  The study will be conducted as a single-arm cohort, without randomization. The sample size calculation indicated that 274 specimens would be sufficient to estimate a proportion of 21.1% with a 95% confidence interval and an absolute error of ±5%. Regarding the procedures, after induction of general anesthesia and standard mastectomy marking, the nipple–areola complex (NAC) will be removed as a full-thickness skin graft for pathological analysis. During surgery, the retroareolar margin will be assessed through frozen section analysis, providing a provisional diagnostic report. The surgical procedure will then proceed as routinely performed. The study will be conducted at the Hospital Municipal Vila Santa Catarina, with an estimated sample of 274 mastectomy specimens. The primary objective is to analyze clinical, radiological, and pathological factors associated with involvement of the nipple-areola complex (NAC) graft, while the secondary objective is to assess the accuracy of intraoperative evaluation of the retroareolar margin compared to the final pathological examination. The reference period for case collection will be from February 2025 to March 2026, followed by data analysis until July 2026 and preparation of the scientific manuscript by January 2027. This is a prospective study without long-term clinical follow-up of patients, as the analysis is limited to the surgical period and pathological processing of the specimens.

  pt-br

  O estudo será conduzido no Hospital Municipal Vila Santa Catarina, com uma amostra estimada de 274 espécimes de mastectomia. O objetivo principal é analisar fatores clínicos, radiológicos e patológicos associados ao comprometimento do enxerto do complexo areolopapilar (CAP), enquanto o objetivo secundário é avaliar a acurácia do exame intraoperatório da margem retropapilar em comparação ao anatomopatológico definitivo. O período de referência para a coleta dos casos será de fevereiro de 2025 a março de 2026, seguido da avaliação dos resultados até julho de 2026 e da elaboração do artigo científico até janeiro de 2027. Trata-se de um estudo prospectivo, sem acompanhamento clínico prolongado das pacientes, visto que a análise se restringe ao período cirúrgico e ao processamento anatomopatológico do material.

• Descriptors:

  en

  C04.588.180 Breast Neoplasms

  pt-br

  C04.588.180 Neoplasias da Mama

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 03/18/2025 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  274	F	18 Y	0

• Inclusion criteria:

  en

  Women over 18 years old with a diagnosis of Breast Carcinoma; Women with an indication for Mastectomy with excision of the nipple-areola complex

  pt-br

  Mulheres acima de 18 anos com diagnóstico de Carcinoma Mamário; Mulheres com indicação de Mastectomia com exérese do complexo areolopapilar

• Exclusion criteria:

  en

  Nipple-areola complex presenting with clinical ulceration; Inflammatory carcinoma; Treatment performed at another institution; Refusal to sign the Informed Consent Form

  pt-br

  Complexo areolopapilar apresentando ulceração clínica; Carcinoma Inflamatório; Tratamento realizado em outro serviço; Recusa em assinar o Termo de Consentimento Livre e Esclarecido

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase

Outcomes

• Primary outcomes:

  en

  To evaluate whether clinical and radiological factors may be associated with pathological involvement of the nipple–areola complex graft in mastectomy specimens.

  pt-br

  Avaliar se fatores clínicos e radiológicos podem estar associados ao comprometimento patológico do enxerto do complexo areolopapilar em espécimes de mastectomia.

• Secondary outcomes:

  en

  To evaluate the accuracy of intraoperative pathological examination of the retroareolar margin, comparing it with the definitive pathological analysis of the specimen.

  pt-br

  Avaliar a acurácia do exame anatomopatológico intraoperatório da margem retropapilar, comprando com o exame anatomopatológico definitivo da peça

Contacts

• Public contact
  • Full name: Gabriel Salum DAlessandro
  • • Address: Av. Albert Einstein, 627
    • City: São Paulo / Brazil
    • Zip code: 05652-900
  • Phone: +55 11 2151-5654
  • Email: dr.gabriel.dalessandro@gmail.com
  • Affiliation: Hospital Israelita Albert Einstein - São Paulo
   
• Scientific contact
  • Full name: Gabriel Salum DAlessandro
  • • Address: Av. Albert Einstein, 627
    • City: São Paulo / Brazil
    • Zip code: 05652-900
  • Phone: +55 11 2151-5654
  • Email: dr.gabriel.dalessandro@gmail.com
  • Affiliation: Hospital Israelita Albert Einstein - São Paulo
   
• Site contact
  • Full name: Gabriel Salum DAlessandro
  • • Address: Av. Albert Einstein, 627
    • City: São Paulo / Brazil
    • Zip code: 05652-900
  • Phone: +55 11 2151-5654
  • Email: dr.gabriel.dalessandro@gmail.com
  • Affiliation: Hospital Israelita Albert Einstein - São Paulo
   

Additional links:

• Download in ICTRP format