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NCT05724407
Molecular Signature for Breast Cancer
Conditions: Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Enrollment: 220
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
The main objective of this study is to evaluate and compare the diagnostic performance of a diagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer (HER2, Ki67 Index, Mitoses, Estrogen Hormone Receptor, Hormone Progesteron receptors hormone of Progesteronereceptor) integrating an automatic analysis algorithm compared to a reference (gold standard defined as the rereading by at least two different anatomopathologists according to the standard method of care) in order to show the non-inferiority of the automatic analysis algorithm compared to this gold standard.
Eligibility Criteria
Inclusion Criteria:Patients over 18 years of ageUnderstanding FrenchWith symptoms of breast cancer that required a biopsy (microbiopsy or macrobiopsy or surgical biopsy) and pathological examination diagnosing breast cancerFirst diagnosis of invasive breast cancercarcinomaAffiliated to a social security systemAgreeing to participate in the studyExclusion Criteria:Refusal to participate in the studyNot affiliated to the social security systemMinor or under legal protectionPatient with a history of breast cancerPatient previously treated for breast cancerPatient who has relapsed from breast cancer treatmentNon ductal or non lobular invasive breast cancer carcinoma
Source: ClinicalTrials.gov (NCT05724407). StuddyBuddy aggregates publicly available trial information.