We hypothesize that among breast cancer patients with a grade 3 breast fibrosis the RILA frequency is significantly lower compared to the RILA frequency among breast cancer patients with no fibrosis.
ID
Bron
Verkorte titel
Aandoening
Radiation Induced Fibrosis, Breast Cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary objective of this study is to assess the association between RILA frequency and RIF after BCT and radiotherapy among breast cancer patients.
Achtergrond van het onderzoek
Around 5% of all patients treated with breast conserving therapy (BCT) are affected by a severe form of radiation-induced fibrosis (RIF) of the treated breast. RIF is characterized by reduced tissue flexibility, reduced compliance or stricture. There is a large patient-to-patient variability of being at risk for RIF. The severity of RIF is known to be affected by differences in treatment characteristics and individual radiosensitivity. An important biological difference associated with differences in individual radiosensitivity, is the presence of senescence in cells. Senescence is a permanent arrest state of the cell division. Senescence can be induced by Ionizing Radiotherapy (IR) in fibroblasts and other cellular types. The senescence characteristic of reduced apoptosis can possibly be used to assess the risk of RIF. The risk of RIF was reported to show a positive correlation with reduced apoptosis in the Radiation-Induced Lymphocyte Apoptosis (RILA) assay. Previous studies have shown that a low RILA frequency is associated with a higher risk of developing RIF. The Primary objective of this study is to assess the univariate association between RILA frequency and RIF after BCT among breast cancer patients. We hypothesize that among breast cancer patients with a grade 3 breast fibrosis the RILA frequency is significantly lower compared to the RILA frequency among breast cancer patients with no fibrosis.
Doel van het onderzoek
We hypothesize that among breast cancer patients with a grade 3 breast fibrosis the RILA frequency is significantly lower compared to the RILA frequency among breast cancer patients with no fibrosis.
Onderzoeksopzet
After inclusion, patients will be invited for a one-off hospital visit for blood withdrawal, skin punch biopsy and questionnaires.
Onderzoeksproduct en/of interventie
• Two 5-ml heparinized blood samples
• Skin punch biopsy
• Three HRQoL questionnaires (BREAST-Q, postoperative BCT module; EORTC QLQ-C30 and BR23)
Publiek
Dr. MD, PhD L.B. Koppert
(010-70) 41161
l.koppert@erasmusmc.nl
Wetenschappelijk
Dr. MD, PhD L.B. Koppert
(010-70) 41161
l.koppert@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Male patients
• Patients who are unable to provide written informed consent or fill out the questionnaires
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL9020 |
Ander register | METC Erasmus Medical Centre : MEC2020-0484 |