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

Centre Oscar Lambret

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Clinical exam; Biological: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT00922961

MAMMOSITE2

Details and patient eligibility

About

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)

Full description

This is an interventional study for the french law

Enrollment: 25 patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

cellular apoptosis

Experimental group

Treatment:

Procedure: Clinical exam

Biological: Blood sample