Association of Radiation-induced Lymphocyte Apoptosis with Radiation Induced Fibrosis after Breast Conserving Therapy”
Recruiting
- Conditions
- Radiation Induced Fibrosis, Breast Cancer
- Registration Number
- NL-OMON21812
- Lead Sponsor
- Erasmus MC Cancer Institute, Dpt. of Surgical Oncology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
• Aged = 18 years
• History of BCT with radiation therapy for non-metastatic, histologically proven invasive breast cancer (pT1-3N0-2a)
• Having = grade 3 fibrosis on the LENT SOMA scale (cases)
• Having with = grade 1 fibrosis on the LENT SOMA scale (controls)
• Adequate understanding of the Dutch or English language
Exclusion Criteria
• Male patients
• Patients who are unable to provide written informed consent or fill out the questionnaires
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the association between RILA frequency and RIF after BCT and radiotherapy among breast cancer patients.
- Secondary Outcome Measures
Name Time Method Secondary objectives include:<br>• The identification of treatment and patient related risk factors of developing RIF<br>• The assessment of the association between RIF and PROs to measure the impact of fibrosis on the quality of life.<br>• To enable future research focusing on RIF, a biobank of prospectively collected fibroblasts derived from skin biopsies will be collected.