Association of Radiation-induced Lymphocyte Apoptosis with Radiation Induced Fibrosis after Breast Conserving Therapy

• Conditions: Radiation induced fibrosis; radiation induced fibrosis; 10006291

• Registration Number: NL-OMON49154
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Females and age 18 years or older
History of BCT with radiation therapy for non-metastatic, histologically proven
invasive breast cancer (pT1-3N0-2a)
Having either * grade 1 (controls) or * grade 3 (cases) fibrosis on the LENT
SOMA scale

Exclusion Criteria

Males

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study outcome is the frequency of radiation-induced apoptosis of<br /><br>CD4+ and CD8+ T-lymphocytes in cases and controls.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study outcomes are treatment and patient related risk factors and<br /><br>health related quality of life.</p><br>