Strovolos

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 collecting detailed clinical and biological data from cancer patients with various tumor types to support advanced translational and clinical cancer research. This platform, called SPECTA, gathers annotated biological samples, imaging data, operative images, environmental assessments, questionnaires, and patient-reported outcomes to improve understanding of tumor biology and patient care over a 5-year period. Participants provide biological materials such as tissue samples that undergo genetic analyses including whole exome sequencing, RNA sequencing, and various genetic panels across multiple research projects within the platform. These analyses support biomarker discovery and other research aims. The platform integrates data collection from several downstream projects using advanced genetic and molecular techniques. During the study, patients are followed with assessments that include collection and confirmation of adequate biological material, clinical data, and patient questionnaires. Researchers monitor quality assurance and compliance with study protocols. The primary outcome focuses on establishing a reliable platform to enhance cancer research and improve patient care over five years.

Researchers are evaluating whether adding preoperative chemotherapy before surgery improves outcomes for patients with high-risk dedifferentiated liposarcoma (DDLPS) and leiomyosarcoma (LMS) located in the retroperitoneal or pelvic areas. This phase III trial compares standard surgery alone to surgery combined with chemotherapy, aiming to increase disease-free survival in these patients. High-risk tumors are carefully defined by specific pathological and imaging criteria to select appropriate participants. Participants are randomly assigned to one of two groups. The standard group undergoes large, en-bloc curative surgery within four weeks of randomization. The experimental group receives three cycles of chemotherapy—doxorubicin plus ifosfamide for high-grade liposarcoma, or doxorubicin plus dacarbazine for leiomyosarcoma—starting within two weeks after randomization. After chemotherapy, operability is reassessed and surgery is performed within three to six weeks following the last chemotherapy cycle. Chemotherapy doses may be adjusted according to guidelines but must meet minimum thresholds. During the study, patients undergo imaging to measure their tumors and provide tumor tissue and blood samples for pathology and research. Eligibility includes performance status, organ function, and use of effective birth control for those of reproductive potential. Researchers monitor disease-free survival over seven years from the first patient's enrollment. Safety, treatment response, and other health assessments are part of the follow-up during and after treatment.

Researchers are conducting a prospective, multicenter study called the CROCO Study to better understand Crohn Disease (CD). This study will follow 600 patients newly diagnosed with CD over a period of 5 years. The goal is to track disease progression and evaluate different treatment strategies by measuring the Le9mann Index at specific intervals. This approach aims to improve knowledge about long-term disease evolution, bowel damage, and disability associated with CD. Participants will receive standard care therapies under a treat-to-target strategy and undergo detailed assessments including Magnetic Resonance Enterography (MRE) at 1 year in some patients. Morphological evaluations using abdominal MRI will be performed at 1, 3, and 5 years after diagnosis. Additional procedures such as ileocolonoscopy, upper endoscopy, and pelvic MRI may also be conducted depending on disease location. Follow-up visits will occur every six months after the first year, with clinical and laboratory markers collected regularly. Throughout the study, researchers will register surgeries and collect disability questionnaires annually. Training sessions will be held for gastroenterologists and radiologists to standardize the evaluation of lesions and the calculation of the Le9mann Index. The primary outcomes measured include the Le9mann Index scores at 1, 3, and 5 years after diagnosis, reflecting the anatomical progression and severity of Crohn Disease.