Radiation Induced Fibrosis, Breast Cancer
Conditions
Interventions
• Two 5-ml heparinized blood samples
• Skin punch biopsy
• Three HRQoL questionnaires (BREAST-Q, postoperative BCT module
EORTC QLQ-C30 and BR23)
Sponsors
Erasmus MC Cancer Institute, Dpt. of Surgical Oncology
Eligibility
Inclusion criteria
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
Exclusion criteria: • Male patients • Patients who are unable to provide written informed consent or fill out the questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary objectives include: • The identification of treatment and patient related risk factors of developing RIF • The assessment of the association between RIF and PROs to measure the impact of fibrosis on the quality of life. • To enable future research focusing on RIF, a biobank of prospectively collected fibroblasts derived from skin biopsies will be collected. | — |
Contacts
Public ContactDr. MD, PhD L.B. Koppert
Dept. of Surgical Oncology, Erasmus MC University Medical Centre, Rotterdam Postbus 2040 3000 CA Rotterdam
Outcome results
None listed