Breast Cancer
Conditions
Keywords
brachytherapy, late cutaneous toxicity
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
Interventions
BIOLOGICALBlood sample
Blood sample taken for the analysis of the rate of CD8 T-Lymphocyte Apoptosis
PROCEDUREClinical exam
Assessment of the esthetic score, and the late cutaneous side effect by 2 physicians
Sponsors
Centre Oscar Lambret
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis | Blood sample during a consultation |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the rate and scores of late fibrosis related to irradiation by mammosite | During a consultation with 2 physicians |
| Assessment of the rate of telangiectasia | During a consultation with 2 physicians |
| Assessment of the rate of sequellar pain | During a consultation with 2 physicians |
| Assessment of the rate of seroma collection | During a consultation with 2 physicians |
| Assessment of the breast esthetic score | During a consultation with 2 physicians |
Countries
France
Outcome results
None listed