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

Breast Cancer Clinical Trial

— MAMMOSITE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922961
• Other study ID #: MAMMOSITE2
• Status: Completed
• Phase: N/A
• First received: June 15, 2009
• Last updated: July 20, 2012
• Start date: September 2008
• Est. completion date: February 2009

Study information

• Verified date: July 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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)

Description:

This is an interventional study for the french law

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

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

• Patient with social security

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Dermatitis, Atopic
• Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis		Blood sample during a consultation	No
Secondary	Assessment of the rate and scores of late fibrosis related to irradiation by mammosite		During a consultation with 2 physicians	No
Secondary	Assessment of the rate of telangiectasia		During a consultation with 2 physicians	No
Secondary	Assessment of the rate of sequellar pain		During a consultation with 2 physicians	No
Secondary	Assessment of the rate of seroma collection		During a consultation with 2 physicians	No
Secondary	Assessment of the breast esthetic score		During a consultation with 2 physicians	No