Node-positive Breast Cancer Clinical Trial
— MUTASOfficial title:
Prospective Trial to Evaluate MUltimodal Targeted Axillary Surgery (MUTAS) Approaches in Breast Cancer Patients With Positive Lymph Nodes.
The present trial will prospectively evaluate the accuracy of both a systematic predefined axillary ultrasound imaging together with tumor load quantification of suspicious and sentinel axillary lymph nodes to predict overall tumor load in the axilla.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | November 15, 2022 |
Est. primary completion date | March 15, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Node-positive breast cancer patients confirmed by biopsy or cytology - Positivity confirmed before the surgical treatment Exclusion Criteria: - Inability to confirm positive lymph nodes by biopsy or cytology - Inability to understand the protocol design - Poor understanding of the Spanish language |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital del Mar | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar | GEICAM |
Spain,
Nicolau P, Gamero R, Rodríguez-Arana A, Plancarte F, Alcántara R, Carreras R, Sabadell D, Vernet-Tomas M. Imaging and pathology features to predict axillary tumor load in breast cancer. J Obstet Gynaecol Res. 2018 Feb;44(2):331-336. doi: 10.1111/jog.13490. Epub 2017 Oct 13. — View Citation
Vernet-Tomás M, Baños N, Sabadell D, Corominas JM, Mestre-Fusco A, Suárez-Piñera M, Carreras R. p53 expression in breast cancer predicts tumors with low probability of non-sentinel nodes infiltration. J Obstet Gynaecol Res. 2015 Jul;41(7):1115-21. doi: 10.1111/jog.12670. Epub 2015 Feb 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients correctly identified as low axillary tumor load carriers by a pre-defined systematic axillary ultrasound imaging workflow | The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of the pre-defined systematic ultrasound imaging workflow for identifying patients wih low axillary tumor load will be reported. Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes. | 24 months | |
Primary | Number of patients correctly identified as low axillary tumor load carriers by the information on tumor load of suspicious and sentinel axillary lymph nodes. | The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of different tumor load cut-off points of the suspicious and sentinel axillary lymph nodes for identifying patients with low axillary tumor load will be reported.Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes. | 24 months | |
Primary | Number of patients correctly identified as low axillary tumor load carriers combining both the pre-defined axillary ultrasound imaging workflow with the information on tumor load of suspicious and sentinel axillary nodes | The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of both the pre-defined systematic axillary ultrasound imaging workflow combined with tumor load information of suspicious and sentinel axillary lymph nodes for identifying patients with low axillary tumor load will be reported.Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes. | 24 months | |
Secondary | Number of infiltrated axillary lymph nodes detected by physical exploration | The difference between the number of positive lymph nodes identified in the final pathology exam and the nodes described as suspicious in physical exploration will be recorded to establish if physical exploration correctly estimates, underestimates or overestimates axillary tumour load. | 24 months | |
Secondary | Number of infiltrated lymph nodes detected by computed tomography | The difference between the number of positive lymph nodes identified in the final pathology exam and the nodes described as suspicious in computed tomography will be recorded to establish if physical exploration correctly estimates, underestimates or overestimates axillary tumour load. | 24 months | |
Secondary | Number of infiltrated lymph nodes detected by magnetic resonance | The difference between the number of positive lymph nodes identified in the final pathology exam and the nodes described as suspicious in magnetic resonance will be recorded to establish if magnetic resonance correctly estimates, underestimates or overestimates axillary tumour load. | 24 months | |
Secondary | Number of patients with low axillary tumor load among menopause status categories | The number of patients with low axillary tumor load in each menopause category will be reported. Patients will be categorized according to their menopausal status (pre-menopause and menopause). | 24 months | |
Secondary | Number of patients with low axillary tumor load among each breast cancer pathology subtype. | The number of patients with low axillary tumor load in each breast cancer pathology subtype (non-specified invasive carcinoma, lobular carcinoma and other carcinomas) will be reported | 24 months | |
Secondary | Number of patients with low axillary tumor load among each breast cancer immunophenotype. | The number of patients with low axillary tumor load in each breast cancer immunophenotypes (luminal , Her2 positive and triple negative carcinomas) will be reported | 24 months | |
Secondary | Number of patients with infiltrated nodes exclusively in the inferior axillary node clearance. | The number of patients with infiltrated nodes exclusively in the inferior axillary node clearance wil be reported. This information shall be obtained from the final pathology report. | 24 months |
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