- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01368744
Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology
Intraoperative Examination of Sentinel Lymph Nodes: Comparison of the OSNA Breast Cancer System to Extensive Frozen Section Histopathology
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Milan, Italie, 435 - 20141
- University of Milan School of Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Male or female;
- 18 years of age or older;
- Diagnosed pre-surgically with T1 or T2 breast cancer without clinical evidence of axillary lymph node involvement and scheduled for surgery including sentinel lymph node dissection;
- Subjects (or the subjects' legal representatives) who have read, understood to the best of their ability and signed the informed consent form.
Exclusion Criteria:
- Subjects diagnosed pre-surgically with large or locally advanced (T3 & T4) breast cancer;
- Pregnant subjects, confirmed by interview with either subject or treating physician;
- Subjects diagnosed with inflammatory breast cancer;
- Subjects diagnosed with ductal carcinoma in situ (DCIS) when breast conservation is to be done;
- Subjects with clinically suspicious, palpable axillary lymph nodes;
- Subjects previously treated for or previously diagnosed with another type of invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma; Subjects with non-invasive carcinoma of the Cervix may also be included in this study.
- Subjects who have received pre-operative systemic therapy;
- Subjects who are incapable of providing written informed consent;
- Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
- Subjects participating in other clinical studies where the SLN evaluation will be negatively impacted by this study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Système de lutte contre le cancer du sein OSNA
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For in vitro diagnostic use only. The OSNA Breast Cancer System is an automated semi-quantitative, in vitro diagnostic test for the rapid detection of greater than (>) 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes and to aid in patient staging. An assay positive + or ++ result indicates the presence of metastasis (> 0.2 mm). An assay positive ++ result predicts the presence of macrometastasis (> 2 mm). Groups: OSNA Breast Cancer System |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Prospectively assess the concordance and performance of the OSNA Breast Cancer System with an extensive intraoperative frozen section protocol for SLNs removed using standard SLN biopsy procedures from breast cancer subjects.
Délai: 3 months
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3 months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OSNA-BC-002
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Tumeurs mammaires
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AstraZenecaRecrutementAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerEspagne, États-Unis, Belgique, Royaume-Uni, France, Hongrie, Canada, Corée, République de, Australie