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| Name | Class |
|---|---|
| Institut Paoli-Calmettes | OTHER |
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This is a phase III, multicentric, single arm study with a sequential design using the exact conditional Poisson test.
The primary objective of this prospective study is to evaluate whether selected breast carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable low local recurrence rates.
450 patients will be included over a period of 4 years and will be followed for a 5 years period (twice a year).
All patients must have a complete preoperative evaluation (bilateral mammography, bilateral breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma (invasive or in situ, all histopathological types, first treatment or relapse).
The study procedure is represented by nipple areola skin-sparing mastectomy followed by immediate breast reconstruction.
After surgery, early and late complications, including specific complications (suffering of the nipple-areolar complexe and suffering of the skin flaps), will be evaluate.
An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be realized throughout the study.
A complementary study, prospective, non-interventional, will be proposed to patients who will benefit from the same surgical technique (NSM) followed by immediate reconstruction, but in the context of preventive surgery (prophylactic surgery for patients mutated or high genetic risk). The aim of this complementary study, which will include a maximum of 60 patients, is to evaluate associated morbidity in prophylactic NSM.
Data will be collected over a 3 months period after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invasive or in situ breast carcinoma. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nipple sparing mastectomy | Procedure | Standardized surgical procedure by :
|
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence rate. | Annual incidence of local recurrence defined by the number of local recurrences (skin, thoracic wall and nipple) among the patient years of follow-up.. | 9 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Early and late complications | Early and late complications will be evaluated using NCI toxicity scale version 4.0. | 9 years. |
| Disease free Survival. | Disease-free survival is the period between the date of origin and date of the first event as defined below, or date of latest news (Censored Data). The events included in the definition of disease-free survival are local recurrence, lymph node metastases, contralateral locations, distant metastases, second breast cancer and death from any causes. |
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Inclusion Criteria:
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Eva JOUVE, Md. | IUCT-O | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Blois | Blois | 41000 | France | |||
| Institut Bergonie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29608972 | Background | Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30. |
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| 9 years. |
| Metastasis Free Survival. | Metastasis free survival is defined as the time from inclusion until the date of metastasis recurrence or the date of the latest news (Censored data). | 9 years. |
| Overall Survival. | Overall survival is defined as the time from inclusion until the date of death or the date of the latest news (Censored data). | 9 years |
| Aesthetic evaluation. | The aesthetic evaluation will be realized by both the surgeon and the patient using to the Licket scale. | 9 years. |
| Quality of life. | The quality of life will be evaluated according to the Breast-Q questionnaire. | 9 years. |
| Bordeaux |
| 33076 |
| France |
| Pôle santé Léonard de Vinci | Chambray-lès-Tours | 37170 | France |
| Centre Georges Francois Leclerc | Dijon | 21079 | France |
| Hôpital privé Drôme Ardèche | Guilherand-Granges | 07500 | France |
| Clinique du Mail | La Rochelle | 17000 | France |
| Centre Hospitalier Universitaire Grenoble Alpes | La Tronche | 38700 | France |
| Clinique Saint Amé | Lambres-lez-Douai | 59552 | France |
| Hopital de Levallois-Perret | Levallois-Perret | 92300 | France |
| Centre Oscar Lambret | Lille | 59000 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| Hôpital de la Croix Rousse | Lyon | 69317 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Clinique Clementville | Montpellier | 34070 | France |
| Centre Hospitalier Universitaire de Montpellier | Montpellier | 34295 | France |
| Institut Du Cancer de Montpellier | Montpellier | 34298 | France |
| Centre Antoine LACASSAGNE | Nice | 06189 | France |
| Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris | Paris | 75015 | France |
| Ap-Hp - Hopital Tenon | Paris | 75020 | France |
| CHRU Lyon Sud | Pierre-Bénite | 69495 | France |
| Centre Hospitalier de Poitiers | Poitiers | 86 000 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Clinique Mathilde | Rouen | 76175 | France |
| Hôpital René Huguenin | Saint-Cloud | 92210 | France |
| Clinique Mutualiste Chirurgicale | Saint-Etienne | 42013 | France |
| Hôpital Privé de la Loire | Saint-Etienne | 42100 | France |
| Etablissement Rennais du Sein - CHP St Grégoire | Saint-Grégoire | 35760 | France |
| INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau | Saint-Herblain | 44805 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Clinique Saint Jean | Toulouse | 31077 | France |
| Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002278 | Carcinoma in Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D015414 | Mastectomy, Subcutaneous |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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