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Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast (DCIS)

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ClinicalTrials.gov Identifier: NCT03002766
Recruitment Status : Completed
First Posted : December 26, 2016
Last Update Posted : December 26, 2016
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:

By this non-randomized prospective study, it's evaluated the outcome of patients underwent BCS for DCIS at whom an established score system to address adjuvant therapies have been prospectively applied, according to the wideness of free margins.

Between March 2000 and April 2006, 224 patients were enrolled and followed within the study.


Condition or disease Intervention/treatment Phase
Carcinoma Breast Procedure: Breast conservative surgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast.
Study Start Date : March 2000
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006



Primary Outcome Measures :
  1. Ipsilateral Breast Tumor Recurrence (IBTR) [ Time Frame: six years ]

Secondary Outcome Measures :
  1. Contralateral breast cancer (CBC) [ Time Frame: six years ]
    the side effects of radiotherapy may outweigh the reduction in the risk of IBTR



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >18 years;
  • female candidate to breast conservative surgery

Exclusion Criteria:

  • female with previous omolateral or controlateral breast cancer;
  • female with previous radiotherapy (RT).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002766


Locations
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Italy
Massimiliano Gennaro
Milano, MI, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Massimiliano Gennaro, MD Fondazione IRCCS Istituto Nazionale Tumori

Publications of Results:

Other Publications:
Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J AM Stat Assoc 53:457-481, 1958.

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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT03002766     History of Changes
Other Study ID Numbers: 67/13
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Breast Carcinoma In Situ
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms by Site
Breast Diseases
Skin Diseases