Groupe d'Etude en Oncologie du Quebec

Titre	Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ Defined by a Molecular Expression Assay Combined With Clinico-Pathological Features
Protocole ID	ELISA
ClinicalTrials.gov ID	NCT04797299
Type(s) de cancer	Sein
Phase	Autres
Type étude	Autre
Institution	CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
Ville	Montréal
Investigateur(trice) principal(e)	Dr Jean-Marc Bourque
Coordonnateur(trice)	Silvine Benth 514-890-8000
Statut	Actif en recrutement
Date d'activation	20-06-2024
Critètes d'éligibilité	Female patient > 45 years of age with DCIS without microinvasion. Tumour size ≤ 2.5cm. Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision. Oncotype DX DCIS score < 39 and predicted 10-year risk of LR <10%.
Critètes d'exclusion	Multifocal DCIS. History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast. Synchronous or previous invasive or non-invasive breast cancer. Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers. ECOG performance status ≥3. Life expectancy <10 years. Geographic inaccessibility for follow-up. Inability to provide informed consent.

Groupe d'étude en oncologie du Québec