Saint Nicolas

Researchers are evaluating the use of Antimfcllerian Hormone (AMH) as a marker to predict future infertility risk in young girls who have been treated for cancer or benign diseases with chemotherapy and/or pelvic irradiation. The study focuses on girls aged 3 to 14 years and aims to identify those with reduced ovarian reserve after treatment, especially among those who have gone through normal puberty. The goal is to improve fertility preservation counseling and care for patients at low or moderate risk of premature ovarian failure. Participants are grouped by their risk level of ovarian failure: high risk (those undergoing conditioning therapy for bone marrow transplant or pelvic irradiation), moderate/low risk (patients treated with chemotherapy regimens with moderate or low risk), and no risk (control group with no gonadotoxic treatment). No intervention is applied; rather, the study monitors AMH levels and other hormonal markers before and after treatment, with follow-ups continuing until participants reach 18 years old. During the study, participants will have hormonal tests including AMH, FSH, estradiol, testosterone, and LH at multiple time points: at screening, one year after screening, annually for the first three years, and then every two years until age 18. Pubertal development is assessed yearly through Tanner staging and bone age X-rays. Menstrual function and oncological outcomes are also tracked throughout. The study aims to better understand ovarian reserve changes and identify patients who may benefit from fertility preservation strategies.

Researchers are evaluating treatments for children and young adults with high-risk neuroblastoma, a type of cancer affecting nerve tissue. This study focuses on patients with advanced stages of the disease, including those with tumors that have an amplified MYCN gene, which is linked to a higher risk of relapse. The trial is part of the European SIOP Neuroblastoma Group (SIOPEN) and aims to improve outcomes using various chemotherapy and immunotherapy strategies. Participants receive a rapid, intensive induction chemotherapy regimen called Rapid COJEC, followed by peripheral blood stem cell collection and surgery to remove the primary tumor. Depending on their response, some patients may receive additional chemotherapy cycles. Consolidation treatment involves high-dose chemotherapy with busulfan and melphalan (BuMel MAT), stem cell rescue, and radiotherapy. The study also tests immunotherapy using the ch14.18/CHO antibody (Dinutuximab beta, Qarziba®) given as a continuous infusion, with or without subcutaneous aldesleukin (IL-2), alongside isotretinoin (13-cis-RA). Patients diagnosed after June 2017 receive immunotherapy without IL-2 as standard care outside trials. During the study, participants undergo various assessments including tumor response evaluations and laboratory tests to monitor their health and treatment effects. The main outcomes measured are event-free survival up to three years and complete metastatic response within about 95 days after induction therapy. Safety and long-term effects are followed regularly over at least five years. The study collects biological tumor samples to assess prognostic factors and requires informed consent and ethical approval before participation.

Researchers are conducting a multinational clinical trial called LBL 2018 to study treatment approaches for children and adolescents newly diagnosed with lymphoblastic lymphoma. The trial aims to see if replacing prednisone with dexamethasone in induction therapy can reduce relapse involving the central nervous system (CNS) and if intensified treatment improves event-free survival in high-risk patients. Participants are grouped into high risk and standard risk categories based on disease characteristics to guide treatment and randomization. The study compares standard chemotherapy treatment using prednisone to an experimental approach using dexamethasone during induction. Patients in standard risk groups receive induction, consolidation, extra-compartment phases, reintensification (for some), and maintenance therapy over 24 months. High-risk patients can be randomized again after induction to receive either standard or intensified chemotherapy including additional PEG asparaginase and alternating high-risk courses. Patients with CNS involvement receive intensified intrathecal therapy and additional doses during maintenance without cranial irradiation. Participants undergo treatment phases lasting up to 24 months with follow-up for up to 7.25 years to monitor relapse rates and event-free survival. Evaluations include disease status, CNS involvement, and response to therapy. The trial collects pathology and genetic samples for risk stratification and monitors safety and treatment effects across multiple international centers. This comprehensive study seeks to improve outcomes while reducing CNS relapses in young patients with lymphoblastic lymphoma.

This research aims to evaluate the effectiveness, safety, and tolerability of atogepant, a medicine approved for preventing migraine, when used to treat migraine attacks quickly. The study focuses on adults aged 18 to 75 years who have a history of moderate to severe migraine attacks. It includes a double-blind phase where neither participants nor doctors know who receives atogepant or placebo, followed by an open-label phase where everyone receives atogepant. The study is conducted at about 160 sites worldwide with around 1300 participants. Participants will receive both atogepant and placebo in a random sequence to treat qualifying migraine attacks during the double-blind phase. After treating four migraine attacks this way, participants will enter an open-label phase lasting until week 24, during which they will receive atogepant for any additional migraine attacks. Treatments are given as oral tablets. Throughout the study, participants will attend regular hospital or clinic visits and telephone check-ins. They will complete electronic diaries with questionnaires about their migraines and treatment effects. Medical assessments, blood tests, and monitoring for side effects will be conducted. The main outcome measured is the percentage of participants who experience freedom from pain two hours after taking the study medication for their first treated migraine attack, observed over about 16 weeks.

Researchers are evaluating the safety and performance of the PRIMUS System, a device designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves, for treating resistant migraine. This study focuses on adults diagnosed with chronic or high-frequency episodic migraine who have not responded to multiple preventive medications. The goal is to assess both clinical benefit and safety over a 12-week period. Participants receive treatment using the Salvia PRIMUS System, which delivers neurostimulation to specific nerve branches associated with migraine. The study is randomized, double-blind, and controlled, ensuring a careful comparison of outcomes. The investigational device is applied with attention to device safety and effectiveness. During the study, participants are monitored for safety and effectiveness over 12 weeks. Assessments include clinical evaluations to track migraine symptoms and any potential side effects. Throughout the trial, researchers collect data on treatment performance, patient response, and overall well-being to understand the device's impact on resistant migraine.