Management of Ductal Carcinoma in Situ or Pure Micro-invasive Extended Breast (CINNAMOME)

August 24, 2016 updated by: Institut Bergonié

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • Institut Bergonie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Surgery
sentinel node biopsy and mastectomy
Procedure: sentinel node biopsy and mastectomy
sentinel node biopsy and mastectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Investigators

  • Study Chair: TUNON DE LARA Christine, MD, Institut Bergonie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 26, 2013

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2007-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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