Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer (MAMMOSITE2)

July 20, 2012 updated by: Centre Oscar Lambret

25 patients, treated by brachytherapy in a phase II study "Mammosite" (from 2003 to 2005), will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due to brachytherapy.

During this consultation, a blood sample will be taken for analysis ( rate of CD8 T-Lymphocyte Apoptosis)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an interventional study for the french law

Study Type

Interventional

Enrollment (Actual)

25

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
      • Lille, France, 59020
        • Centre Oscar Lambret

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All patient treated by exclusive per-operative brachytherapy in the prior study Mammosite for breast cancer
  • Patient with social security

Exclusion Criteria:

  • Not applicable

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cellular apoptosis
Biological: Blood sample
Blood sample taken for the analysis of the rate of CD8 T-Lymphocyte Apoptosis
Procedure: Clinical exam
Assessment of the esthetic score, and the late cutaneous side effect by 2 physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis
Time Frame: Blood sample during a consultation
Blood sample during a consultation

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the rate and scores of late fibrosis related to irradiation by mammosite
Time Frame: During a consultation with 2 physicians
During a consultation with 2 physicians
Assessment of the rate of telangiectasia
Time Frame: During a consultation with 2 physicians
During a consultation with 2 physicians
Assessment of the rate of sequellar pain
Time Frame: During a consultation with 2 physicians
During a consultation with 2 physicians
Assessment of the rate of seroma collection
Time Frame: During a consultation with 2 physicians
During a consultation with 2 physicians
Assessment of the breast esthetic score
Time Frame: During a consultation with 2 physicians
During a consultation with 2 physicians

Collaborators and Investigators

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

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Yazid BELKACEMI, MD, Centre Oscar Lambret

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

September 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

June 15, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

July 23, 2012

Last Update Submitted That Met QC Criteria

July 20, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAMMOSITE2

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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