Back to resultsResearch for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer (MAMMOSITE2)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Clinical exam
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring brachytherapy, late cutaneous toxicity
Eligibility Criteria
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
Sites / Locations
- Centre Oscar Lambret
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cellular apoptosis
Arm Description
Outcomes
Primary Outcome Measures
Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis
Secondary Outcome Measures
Assessment of the rate and scores of late fibrosis related to irradiation by mammosite
Assessment of the rate of telangiectasia
Assessment of the rate of sequellar pain
Assessment of the rate of seroma collection
Assessment of the breast esthetic score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00922961
Brief Title
Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer
Acronym
MAMMOSITE2
Official Title
Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
Detailed Description
This is an interventional study for the french law
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
brachytherapy, late cutaneous toxicity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cellular apoptosis
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
Blood sample taken for the analysis of the rate of CD8 T-Lymphocyte Apoptosis
Intervention Type
Procedure
Intervention Name(s)
Clinical exam
Intervention Description
Assessment of the esthetic score, and the late cutaneous side effect by 2 physicians
Primary Outcome Measure Information:
Title
Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis
Time Frame
Blood sample during a consultation
Secondary Outcome Measure Information:
Title
Assessment of the rate and scores of late fibrosis related to irradiation by mammosite
Time Frame
During a consultation with 2 physicians
Title
Assessment of the rate of telangiectasia
Time Frame
During a consultation with 2 physicians
Title
Assessment of the rate of sequellar pain
Time Frame
During a consultation with 2 physicians
Title
Assessment of the rate of seroma collection
Time Frame
During a consultation with 2 physicians
Title
Assessment of the breast esthetic score
Time Frame
During a consultation with 2 physicians
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yazid BELKACEMI, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
12. IPD Sharing Statement
Learn more about this trial
Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer
We'll reach out to this number within 24 hrs