RecruitingNCT05835739

InheriteD brEast caNcer iTalian regIsTrY A Retrospective-prospective Observational Cohort Study to Evaluate Cancer Prevention Strategies in Women With a Deleterious Mutation in BRCA1-2


Sponsor

Centro di Riferimento Oncologico - Aviano

Enrollment

78 participants

Start Date

Aug 27, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of the study is to obtain and centralize data about cancer prevention strategies in women with a germline deleterious mutation in BRCA1-2 with or without a history of breast cancer in Italy


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria12

  • Cohort A (Retrospective):
  • Female sex
  • Age ≥ 18 years
  • Signed informed consent
  • Documented germline deleterious mutation in BRCA1 and/or BRCA2 in people with: i) No history of cancer ii) Radically treated breast cancer iii) Stage IV breast cancer diagnosed after BRCA1-2 mutation detection
  • Admission to the participating Center since 1st of January 2010, prior to site activation
  • Cohort B (Prospective):
  • Female sex
  • Age ≥ 18 years
  • Signed informed consent
  • Documented germline deleterious mutation in BRCA1 and/or BRCA2 in people with: i) No history of cancer ii) Radically treated breast cancer iii) Stage IV breast cancer diagnosed after BRCA1-2 mutation detection
  • Admission to the participating Center after site activation

Exclusion Criteria6

  • Cohort A/B (Retrospective/Prospective):
  • \. Other malignancies diagnosed within five years prior to BRCA1-2 mutation detection, except for:
  • ovarian cancer stage I-II
  • basal or squamous cell carcinoma of the skin
  • melanoma in situ
  • CIS of the cervix

Locations(12)

Centro di Riferimento Oncologico - Aviano

Aviano, Pordenone, Italy

IRCCS AOU San Martino, IST Genova

Genova, Italy

Azienda Ospedaliera Papardo

Messina, Italy

ASST Ovest Milanese

Milan, Italy

Azienda ospedaliera Universitaria di Modena

Modena, Italy

Università degli studi di Napoli Federico II

Napoli, Italy

Azienda AUSL IRCCS - Reggio Emilia

Reggio Emilia, Italy

ASL Roma 1, Santo Spirito

Roma, Italy

IFO - Istituto Regina Elena (Oncologia medica 2)

Roma, Italy

Policlinico Universitario Gemelli

Roma, Italy

Città della salute Torino, PO S. Anna

Torino, Italy

ASU FC Azienda Sanitaria Universitaria Friuli Centrale

Udine, Italy

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NCT05835739


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