Intraductal Carcinoma and Lobular Carcinoma in Situ Clinical Trial
— CINNAMOMEOfficial title:
Management of Ductal Carcinoma in Situ (DCIS) or Pure Micro-invasive (DCIS-MI) Extended Breast, Axillary Node Sentinel Site (GAS) When the Diagnosis is Made by Biopsy and Treatment by Mastectomy Immediately. Descriptive Study
The rate of axillary dissection avoided in patients with Ductal Carcinoma in Situ (DCIS) and a mastectomy indication will be obtained by calculating the proportion of women with GAS in-patient population that will prove to be DCIS or DCIS-MI + CCI. A confidence interval of 95% will be deferred.
| Status | Completed |
| Enrollment | 231 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Older than 18 years. - Preoperative histological diagnosis obtained by biopsy - Ductal carcinoma in situ (DCIS) or pure micro-invasive (DCIS-MI) - Indication of mastectomy - Patient signed informed consent Exclusion Criteria: - Age < 18 years - Infiltrating ductal carcinoma (TCC) diagnosed on biopsy - Pure DCIS diagnosed by lumpectomy - DCIS can take a conservative treatment - Mastectomy chosen by the patient - History of breast carcinoma in situ or invasive ipsilateral - Prior radiotherapy to the ipsilateral breast - History of axillary lateral homo - Patient who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study - Patient deprived of liberty or under guardianship |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Bergonié | Bordeaux | Aquitaine |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Bergonié |
France,
Tunon-de-Lara C, Chauvet MP, Baranzelli MC, Baron M, Piquenot J, Le-Bouédec G, Penault-Llorca F, Garbay JR, Blanchot J, Mollard J, Maisongrosse V, Mathoulin-Pélissier S, MacGrogan G. The Role of Sentinel Lymph Node Biopsy and Factors Associated with Invas — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Highlight the contribution of sentinel node associated with a mastectomy immediately in pure ductal carcinoma in situ (DCIS) and micro-invasive (DCIS-MI) | Highlight the interest of GAS associated with a mastectomy immediately in pure ductal carcinoma in situ (DCIS) and micro-infiltrating (DCIS-MI) with indication of mastectomy in estimating the rate of axillary dissection avoided due a GAS-detected | 2 years | No |
| Secondary | Among women with ductal carcinoma in situ pure (DCIS) and micro-infiltrating (DCIS-MI) and indication of mastectomy | Number and rate of axillary dissection performed immediately during the mastectomy following the discovery of a GAS +, having avoided a surgical procedure later; rate of discordance between biopsy and histology final; detection rate of sentinel axillary lymph nodes (GAS), regardless of nodal status; GAS positive rate in the population of patients in whom the GAS has been detected. 200 patients: 100 patients with a biopsy showing DCIS and an indication of mastectomy and 100 patients with a biopsy showing DCIS-MI and an indication of mastectomy |
2 years | No |