Clinical Trial: Management of Ductal Carcinoma in Situ or Pure Micro-invasive Extended Breast

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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 Immed

Brief Summary: 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.

Detailed Summary:

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).


Sponsor: Institut Bergonié

Current Primary Outcome: Highlight the contribution of sentinel node associated with a mastectomy immediately in pure ductal carcinoma in situ (DCIS) and micro-invasive (DCIS-MI) [ Time Frame: 2 years ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Among women with ductal carcinoma in situ pure (DCIS) and micro-infiltrating (DCIS-MI) and indication of mastectomy [ Time Frame: 2 years ]

  • 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



Original Secondary Outcome: Same as current

Information By: Institut Bergonié

Dates:
Date Received: November 5, 2012
Date Started: January 2008
Date Completion:
Last Updated: August 24, 2016
Last Verified: August 2016