Clinical trials

Background. Definitive chemoradiotherapy represents the standard therapeutic approach for the management of locally advanced cervical cancer. Vitamin D plays an important role in the regulation of cellular growth and differentiation, immune system function, and the modulation of inflammatory processes. Hypovitaminosis D may be associated with the development of cervical cancer, whereas its impact on the effects of oncological treatment remains insufficiently elucidated. The aim of this study is to investigate the predictive significance of vitamin D in patients with locally advanced cervical cancer treated with definitive chemoradiotherapy. Methods. This study is designed as a clinical, observational, prospective cohort study. Patients with locally advanced cervical cancer undergoing definitive chemoradiotherapy at the Clinic for Radiation Oncology, University Clinical Center Kragujevac, will be enrolled. Vitamin D concentrations will be measured before the initiation of treatment in both serum and cervical lavage samples. Baseline vitamin D levels will be analyzed in relation to treatment outcome and the occurrence of acute radiation toxicity. In addition, vitamin D concentrations will be evaluated in the context of clinical and morphological parameters, therapeutic response, and treatment-related toxicity. Expected Results. This study will enable an assessment of the actual significance of pretreatment vitamin D concentrations in serum and cervical lavage as a potential novel biomarker in relation to chemoradiosensitivity and/or chemoradioresistance of cervical cancer, as well as the response of organs at risk, in patients with locally advanced disease.

MICRORAD is a pioneering 48-month translational research project that investigates the potential health and environmental impacts of micro- and nanoplastics (MNPs) released from medical devices when exposed to ionizing radiation. In radiation oncology, thermoplastic masks (TPMs) are standard immobilization tools, particularly for head and neck (HN) cancer patients. Globally, approximately 2.65 million TPMs are used annually in the radiotherapy of HN cancer patients and with an additional 8 to 10 million for other tumor types. TPMs are repeatedly subjected to high-energy X-rays and frequent handling, raising concerns about polymer degradation and the release of MNPs, which may interfere with treatment efficacy or contribute to radiation toxicity. MICRORAD is the first translational study to explore this phenomenon by integrating clinical oncology, materials science, radiobiology, and data science. The project will analyze radiation-induced changes in TPMs, quantify MNP release, and assess their biological effects through in vitro, in vivo, and clinical studies. Using advanced detection techniques, the project will characterize MNPs and trace their biodistribution, while a clinical pilot will correlate MNP exposure with treatment outcomes. Data integration, biostatistics, and AI-based modeling will support the translation of findings into clinical guidelines, policy briefs, and public communication. A multidisciplinary team will collaborate to ensure real-world impact. By bridging oncology and environmental health, MICRORAD aims to establish eco-oncology as a new field, contributing to patient safety and sustainable innovation.

FERTIMPACT is a prospective clinical study based on the hypothesis that exposure to micro- and nanoplastics (MNPs) is associated with impaired reproductive function. The study will quantify MNPs in human reproductive biospecimens (semen, follicular fluid, endometrial samples, stool and serum) and evaluate their association with clinically relevant fertility parameters, including semen, follicular fluid, and endometrial samples quality, and assisted reproductive technology (ART) outcomes. By integrating biomonitoring with standardized clinical assessment, the study aims to provide robust evidence on exposure-effect relationships in real-world populations undergoing infertility evaluation. This will contribute to improved understanding of environmental determinants of reproductive health and support future risk assessment strategies.