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
18 Years
N/A
Female
Intraductal Carcinoma and Lobular Carcinoma in Situ
Trial Information
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 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 (after the final histology). A confidence interval of
95% will be deferred (binomial).
The rate of axillary dissection avoided in patients with DCIS-MI and an indication of
mastectomy is obtained by calculating the proportion of women with a GAS-all women with
DCIS-MI and an indication of mastectomy. A confidence interval of 95% will be deferred
(binomial).
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Highlight the contribution of sentinel node associated with a mastectomy immediately in pure ductal carcinoma in situ (DCIS) and micro-invasive (DCIS-MI)
Outcome Description:
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
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
TUNON DE LARA Christine, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Bergonié
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
IB2007-40
NCT ID:
NCT01841749
Start Date:
January 2008
Completion Date:
December 2010
Related Keywords:
- Intraductal Carcinoma and Lobular Carcinoma in Situ
- Breast cancer
- Carcinoma
- Carcinoma in Situ
- Carcinoma, Intraductal, Noninfiltrating
- Carcinoma, Lobular
- Carcinoma, Ductal, Breast
- Carcinoma, Ductal
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