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MAGNETO is a French medico-economic study on preoperative localization in breast cancer surgery. The main objective is to conduct a cost-consequence analysis comparing magnetic clip localization with the use of metallic wires for the preoperative identification of non-palpable breast lesions. The choice of localization method is left to the physician's and center's discretion. The study is non-interventional (with only questionnaires and data collection), prospective, and multicenter, with patient follow-up lasting up to six months after breast surgery.
The MAGNETO study is a non-interventional, prospective, and multicenter study. It includes two cohorts: one using magnetic clip localization and the other using metallic wire localization.
Patients are enrolled by the surgeon during the preoperative consultation validating the conservative surgery with preoperative localization. The choice of cohort is left to the discretion of the center based on their routine practice. Baseline data, including patient and disease characteristics, are collected.
Depending on the assigned cohort, localization is performed either with a magnetic clip or a metallic wire. A mammogram is then performed to assess the correct positioning of the marker and its distance from the target lesion. At this stage, the radiologist completes a Likert scale satisfaction questionnaire.
Breast-conserving surgery is performed according to the hospital's standard practices. On the day of the procedure, the surgeon also completes a Likert scale satisfaction questionnaire.
Patients complete quality of life (EQ-5D-5L) and satisfaction questionnaires at several points throughout the study. Postoperative complications are also recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| magnetic clip localization | The preoperative localization can be performed using several techniques, magnetic clip localization will be use in this cohort |
| |
| wire localization | The preoperative localization can be performed using several techniques, wire localization will be use in this cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic clip localization | Procedure | magnetic clip localization for preoperative localization for breast cancer surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the average total cost of patient care with magnetic clip localization versus the use of a hookwire, up to 6 months post-surgery | Effectiveness of localization in terms of lesion identification (did the localization, based on the pathological report, allow the lesion to be located in the breast?)
| 6 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life of patientes | Quality of life assessed using the 5-level EQ-5D version (EQ-5D-5L).The questionnaire assesses 5 dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression). Each dimension is rated on 5 levels (from 1 = no problems to 5 = extreme problems). | At inclusion, 15 to 30 days after surgery and 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
cisgender female with breast cancer
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Patients recruited in 7 centers spread across France
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Severine Metzger | Contact | +33 (0)4 78 78 27 86 | severine.metzger@lyon.unicancer.fr | |
| Marie Osdoit, Dr | Contact | Marie.OSDOIT@lyon.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon Hopital de la Croix rousse | Recruiting | Lyon | 69004 | France |
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| metallic wire localization. | Procedure | metallic wire localization for preoperative localization for breast cancer surgery |
|
| Breast cancer surgery | Procedure | Patient with invasive or in situ breast carcinoma, presenting with a unifocal and unilateral lesion, requiring a first-line breast-conserving treatment with preoperative localization, regardless of the associated lymph node procedure |
|
| Satisfaction of radiologist and surgeon | Questionnaire to evaluate the satisfaction of radiologist after the maker placement and questionnaire to evaluate the satisfaction of surgeon after the surgery. The score isn't on a scale. | Within 24 hours after the maker placement and within 24 hours after the surgery |
| Patient satisfaction and experience. | Questionnaire after the surgery to evaluated the patient satisfaction and experience. The score isn't on a scale. | 15 to 30 days after surgery |
| Budget impact analysis of pre operative magnetic clip localization versus the use of a hookwire. | The decision to include a Budget Impact Analysis (BIA) in this study is in line with the framework agreement signed in January 2016 between the Economic Committee for Medicinal Products (Comité Economique des Produits de Santé - CEPS, in French) and the Pharmaceutical Industry (Les Entreprises du Médicament - LEEM, in French), which advises the implementation of a BIA in addition to the medico-economic study. The BIA will strictly comply with the HAS requirements presented in its methodological guide for BIA. A budget impact model (BIM) will be developed with the French National health insurance perspective. The cost of the current (hookwire) or new intervention (magnetic clip) mix will be assessed. The population to be included in a BIA will be all patients eligible in France for the new intervention during the time horizon of 3 years. The results will be expressed in incremental budget impact in the first, second and third year. | At 1, 2 and 3 years |
| The organisationnal impact of magnetic clip versus metallic wires. | The organizational analysis will be based on performance indicators of magnetic clips compared to metallic wires, such as the number of patient visits to the hospital before surgery, the number of localization procedures performed on the day of the intervention, the length of stay, waiting times, and the number of emergency visits throughout the follow-up period. The stochastic variables (lengths of stay, intervals between stays) will be modeled using appropriate statistical distributions, determined by maximum likelihood estimation based on statistical analyses of the extracted data. | At 6 months |
| Centre Léon Bérard | Recruiting | Lyon | 69008 | France |
|
| Institut de Cancérologie de Lorraine (ICL) | Recruiting | Nancy | 54519 | France |
|
| Hôpital Nord -Ouest Val d'Oise (NOVO) | Recruiting | Pontoise | 95300 | France |
|
| Institut GODINOT | Recruiting | Reims | 51726 | France |
|
| Centre Eugène Marquis | Not yet recruiting | Rennes | 35042 | France |
|
| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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