Lemesos

Researchers are evaluating a personalized treatment approach for men with high-risk localized prostate cancer using advanced artificial intelligence to guide both radiotherapy and androgen deprivation therapy (ADT) durations. This phase II, single-center study focuses on patients classified as low or intermediate risk by the multimodal artificial intelligence (MMAI) classifier and meets National Comprehensive Cancer Network (NCCN) criteria for high-risk prostate cancer. The aim is to improve treatment by escalating the radiation dose directly to the prostate while shortening the usual duration of hormone therapy. Participants will receive a high-dose-rate (HDR) brachytherapy boost to the prostate with a single fraction of 15 Gray (Gy), followed by stereotactic body radiation therapy (SBRT) delivering 25 Gy in five daily fractions to the prostate and seminal vesicles. Alongside radiation, patients will undergo 12 months of androgen deprivation therapy using Goserelin injections, given concurrently and as adjuvant treatment. The treatment schedule includes fiducial marker placement, a 14-day gap, and then five consecutive days of SBRT. Throughout the study, participants will be closely monitored for disease-free survival over five years, along with secondary outcomes such as metastasis-free survival, prostate cancer-specific survival, and overall survival. Assessments will include imaging studies like PSMA-PET and multiparametric MRI, biopsy evaluations, and symptom scoring. Safety and adherence will be tracked, and the study could provide a foundation for future randomized trials comparing this intensified radiotherapy with shorter hormone therapy to current standards. Additionally, the research includes efforts to discover new biomarkers to predict treatment outcomes and impact the socio-economic burden of prostate cancer.

Researchers are evaluating the use of multimodal artificial intelligence (MMAI) to personalize radiation therapy (RT) for male patients with high-risk localized prostate cancer (PCa). This prospective, single-arm phase II study aims to assess an individualized treatment approach combining dose escalation with current standard therapies. Prostate cancer is a common malignancy in men in Europe, and while RT is a mainstay treatment, the optimal radiation dose and target areas remain under investigation. All participants will receive a combination of three treatments: a dose escalation to the prostate using high-dose-rate (HDR) brachytherapy, two years of androgen deprivation therapy (ADT) with Goserelin, and whole-pelvis ultra-hypofractionated radiotherapy (UHF-RT) delivered in five fractions. The HDR brachytherapy involves catheter implantation guided by ultrasound under anesthesia. The UHF-RT delivers 25 Gy in 5 Gy per fraction to the prostate and elective pelvic lymph nodes. ADT is given concurrently and as an adjuvant for a total of 24 months. Participants will undergo imaging assessments such as PSMA-PET, multiparametric MRI, and clinical evaluations to monitor treatment safety and effectiveness. The primary outcome is cumulative genitourinary (GU) toxicity over two years. Secondary outcomes include relapse-free survival, metastatic-free survival, prostate cancer survival, and overall survival. Safety and oncologic results will be closely followed, with translational research also exploring biomarkers to predict treatment outcomes. The study will provide important data on personalized RT in this selected high-risk group over the course of treatment and follow-up.

Researchers are evaluating the NeoPill oral hygiene device to reduce oral bacterial load in adults wearing fixed orthodontic appliances. Maintaining oral hygiene is challenging for these patients due to limited access around brackets and wires, and current methods often use chemical products or disposable tools. This single-arm clinical evaluation aims to gather preliminary clinical and user experience data on the NeoPill device's mechanical cleansing ability. The NeoPill is a reusable, battery-operated device applied inside the mouth for 30 seconds by trained staff. Participants will have oral swabs taken before and immediately after the single application to measure changes in aerobic bacterial load. The swabs will be cultured in a laboratory to count colony-forming units (CFUs) and assess the device's effect. Afterward, participants will complete a questionnaire about comfort, usability, and overall experience with the device. Participants must be adults currently wearing fixed orthodontic appliances and able to consent and comply with the study during one visit. The study involves oral swab collections and one brief device application, with minimal risk of temporary discomfort. All data will be securely stored and anonymized. The primary outcome measured is the difference in aerobic bacterial load immediately before and after the NeoPill use.

Researchers are evaluating two advanced imaging methods, MRI-RSI and PSMA PET, to improve the detection and outlining of tumors inside the prostate for men with newly diagnosed primary prostate cancer. The current standard imaging technique, multiparametric magnetic resonance imaging (mpMRI), is important for guiding targeted biopsies and focal radiotherapy but may underestimate tumor size and show variability between observers. This study aims to compare the new imaging methods with mpMRI to see if they can better detect tumors and reduce variability in tumor delineation. Participants will undergo MRI-RSI imaging of the prostate, PSMA PET-CT scanning, and MR-guided transrectal ultrasound (TRUS) prostate biopsy following standard protocols. These diagnostic tests are non-invasive or minimally invasive and will be used to identify and outline tumor areas within the prostate. The study includes men with intermediate to very high-risk primary prostate cancer, and imaging and biopsy procedures will be done within specified recent time frames. During the study, researchers will measure outcomes such as the sensitivity, specificity, absolute gross tumor volume (GTV), and ROC-AUC at 24 months to assess the accuracy of the imaging methods. Participants will be monitored with these imaging and biopsy tests to compare tumor detection and delineation. The study focuses on men aged 18 or older with newly diagnosed prostate cancer, and participation involves imaging and biopsy assessments following standard clinical protocols.

Researchers are investigating the use of elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer who have a relapse detected by circulating tumor DNA (ctDNA). This international, multi-center, randomized, open-label phase III trial aims to determine if elacestrant offers a benefit over current endocrine treatments in this group of patients without distant metastases. The study includes a lengthy ctDNA screening phase to identify eligible participants and monitor their disease status over time. The study begins with a ctDNA screening phase, where patients receive standard adjuvant endocrine therapy such as tamoxifen, letrozole, anastrozole, or exemestane, and have blood collected every six months for ctDNA testing until about 5.7 years after enrollment ends. Those who test positive for ctDNA and show no distant metastasis on imaging will be randomized within four weeks to continue their current endocrine therapy or switch to elacestrant taken orally at 400 mg daily. Treatment duration varies based on prior endocrine therapy exposure, ranging from two to seven years. After treatment, further care is at the physician's discretion. Participants will have frequent follow-up visits with ctDNA testing at weeks 4 and 16 post-randomization and every 16 weeks thereafter for up to three years. Imaging studies including mammograms, bone scans, and CT scans will be conducted regularly to monitor for distant metastases or new cancers. The main outcome measured is distant metastasis-free survival, assessed up to 6.25 years following the first patient enrollment. The study ends when all patients complete their visits or discontinue for reasons such as withdrawal, loss to follow-up, or death, and data is fully analyzed and finalized.

Researchers are evaluating the effectiveness of a multifactorial education and support program aimed at preventing cancer-related cachexia syndrome in patients undergoing anti-cancer treatment, along with their family caregivers. The study focuses on patients diagnosed with solid tumors who are either normal or in the pre-cachexia stage, and it addresses the challenges of malnutrition and cachexia during cancer therapy. Participants and their nominated family caregivers will be randomly assigned to either an intervention or control group. Those in the intervention group will participate in a 12-week multimodal program that includes four meetings with a cancer nurse and clinical dietician. Each meeting, lasting about 30 minutes, involves blood tests (CRP, Albumin levels), body composition measurements, questionnaires, and education on diet and symptom management related to their cancer treatment. Throughout the 12 weeks, assessments will be done at baseline and at weeks 4, 8, and 12 to monitor changes from baseline in the pre-cachexia stage according to cachexia criteria. Researchers will track body composition, laboratory results, and patient-reported outcomes to evaluate the program's impact. The study also involves ongoing monitoring and support for both patients and their caregivers during the treatment period.

Researchers are studying elderly patients aged 65 and older with locally advanced head-and-neck squamous cell carcinoma (HNSCC) to better understand the outcomes of definitive chemotherapy and radiotherapy treatments. This study focuses on cancers in the oral cavity, oropharynx, hypopharynx, and larynx, aiming to evaluate overall survival and progression-free survival. The study also explores how modern radiotherapy techniques like intensity-modulated radiotherapy (IMRT), supportive care, and different chemotherapy schedules may affect treatment results compared to older data. The research collects retrospective data from multiple centers and countries, examining patients who began primary treatment since 2005. It compares patients who received chemotherapy combined with radiotherapy against those who had radiotherapy alone. The study looks at treatment details such as chemotherapy fractionation schedules and modern radiation methods, adjusting for patient age, health status, and other factors that may influence outcomes. Participants' survival is tracked for up to 5 years to measure overall survival as the primary outcome. Data analysis accounts for patient characteristics like comorbidities and performance status to understand how these impact treatment effectiveness. This study helps provide insights into the best care approaches for this vulnerable elderly population undergoing definitive (chemo-)radiation for advanced HNSCC.

Researchers are investigating how genetic modifiers influence hemoglobinopathies, including sickle cell disease and beta-thalassemia. These diseases vary widely in severity, and while some genetic factors have been identified, more are believed to exist that impact disease outcomes. This large-scale, multi-ethnic genome-wide association study (GWAS) aims to discover new genetic modifiers, validate known ones, pool existing genetic data, standardize disease descriptions, and develop risk scores to better classify patients. The study will perform GWAS using SNP chips on blood samples collected during routine clinical visits or existing biobank DNA samples. Participants with various hemoglobinopathy genotypes will be included without restrictions on gender or ethnicity. The research will analyze genetic factors related to survival, complications like stroke, renal impairment, pain syndromes, and responses to treatments such as hydroxyurea and iron chelation. Data collected will contribute to a comprehensive research resource combining genomic, phenotypic, and functional information. Participants will provide consent and contribute blood samples if DNA is not already available. Researchers will gather worldwide demographic and clinical data from multiple centers. The primary outcome measured over five years is the identification of genetic modifiers influencing disease traits and treatment responses. This extensive monitoring and data collection aim to improve understanding and risk stratification of hemoglobinopathies globally.

Iodine deficiency is a leading cause of thyroid disorders and developmental problems in children, making it one of the most preventable causes of mental impairment. The EUthyroid2 project aims to help prevent iodine deficiency and its related health issues by raising awareness among adolescents in Europe and beyond through educational efforts. This project focuses on improving knowledge about iodine deficiency risks in students aged 13 to 17 years across several countries. The intervention involves educational materials such as the Iodine Feedback Tool, lectures about iodine and health, booklets, exercises, group assignments, and a dedicated webpage. It is conducted as a pre- and post-intervention study without a control group. The intervention is tailored to the local context of each participating country and takes place in three types of schools per country: secondary schools, high schools, and vocational schools. Participants will be assessed at three time points: before the intervention (baseline), 2 to 4 weeks after, and again at 6 to 8 months after the intervention. Data collected will include responses to a new iodine awareness questionnaire, a food frequency questionnaire specific to iodine, and socio-demographic information. The study also includes a process evaluation using surveys and interviews with students and teachers to understand how well the intervention is implemented and received. The overall study involves 4500 participants and aims to support health authorities in reducing iodine deficiency risks sustainably.