Saint Nicolas

This research aims to evaluate the Antimfcllerian Hormone AMH as a predictor of infertility risk in children with cancer or benign diseases treated with chemotherapy andor pelvic irradiation. It focuses on girls aged 3 to 14 years, including prepubertal and pubertal patients, who are classified into high, moderatelow, and no risk groups based on their treatments potential impact on ovarian reserve. The study addresses the challenge of assessing ovarian reserve and fertility preservation needs in young patients who progress normally through puberty but may have impaired ovarian function due to treatment. Participants are observed over several years with no intervention administered as part of the study. They are grouped by their risk category high risk those receiving conditioning therapy for bone marrow transplantation or pelvic irradiation, moderatelow risk patients treated with chemotherapy regimens associated with varying risks, and no risk patients with benign or malignancies not involving gonadotoxic treatment. Assessments include measuring AMH levels and other hormones before and after treatment and during follow-up visits up to 18 years old. During the study, participants undergo evaluations at inclusion, end of treatment, annually for the first three years, and then every two years until age 18. These include blood tests for ovarian reserve hormones AMH, FSH, estradiol, testosterone, LH, pubertal stage assessments using TANNER criteria, menstrual cycle monitoring, and bone age evaluation via X-rays. Researchers will use these measurements to identify patients at risk of premature ovarian failure and to better understand how chemotherapy affects ovarian function in relation to pubertal status.

Researchers are evaluating treatments for children and young adults with high-risk neuroblastoma, a type of cancer affecting nerve tissue. This trial involves patients with certain advanced stages of neuroblastoma, including those with specific genetic markers that indicate a higher risk of relapse. The goal is to assess different chemotherapy regimens, stem cell procedures, surgery, radiation, and immunotherapy combinations to improve outcomes such as event-free survival and metastatic response. The treatment plan includes an intensive chemotherapy induction phase called Rapid COJEC or a modified N7 regimen, followed by peripheral blood stem cell harvest and surgery to remove the primary tumor. Patients then receive myeloablative therapy with either busulfan plus melphalan or another chemotherapy combination, followed by stem cell rescue and radiotherapy. Immunotherapy involves the antibody ch14.18CHO given as a continuous infusion, with or without the immune stimulant Aldesleukin IL-2, alternating with isotretinoin. Some patients may receive additional chemotherapy cycles if needed, and treatment adaptations are made based on disease response and randomization results. Participants undergo regular assessments including evaluation of tumor response, event-free survival over up to three years, and metastatic response within about three months of induction therapy. Biological tumor markers and safety monitoring are also conducted. The study includes up to five years of follow-up to track long-term outcomes and monitor for disease progression or relapse. Treatments and evaluations are carefully scheduled to gather comprehensive data on the effectiveness and safety of these therapies in high-risk neuroblastoma.

This research aims to improve treatment for children and adolescents newly diagnosed with lymphoblastic lymphoma. The trial is a large, international, randomized clinical study involving multiple countries and specialized centers. It focuses on whether using dexamethasone instead of prednisone during the induction phase can reduce relapses in the central nervous system CNS, and for high-risk patients, whether an intensified treatment improves event-free survival compared to standard therapy. Participants are grouped by risk level based on disease characteristics like CNS involvement and genetic markers. All patients first receive a prednisone prephase, then are randomized to either standard induction with prednisone or experimental induction with dexamethasone. Treatment phases include consolidation, extra-compartment phases adjusted by risk group, reintensification for some groups, and maintenance therapy lasting up to 24 months. Patients with CNS involvement receive intensified intrathecal therapy without cranial irradiation. High-risk patients may undergo a second randomization to receive either standard or intensified treatment during later phases. During the study, patients undergo various treatments including chemotherapy drugs such as cyclophosphamide, methotrexate, and PEG asparaginase. Researchers monitor disease relapse involving the CNS and measure event-free survival over a maximum of 7.25 years. Secondary assessments include overall survival, treatment-related toxicity and mortality, adverse events, and molecular markers. The trial involves ongoing follow-up for safety and effectiveness outcomes throughout the study period, which can last several years.

Researchers are evaluating the safety and performance of the PRIMUS System, a device designed to provide neurostimulation to branches of the trigeminal and occipital nerves, for treating resistant migraine. The study focuses on patients with chronic or high-frequency episodic migraine who have not responded to multiple preventive drug therapies. It aims to assess clinical benefits and safety over a 12-week period. Participants will be randomly assigned in a double-blind manner to one of several groups including active therapy modalities or sham therapy. The PRIMUS System delivers subcutaneous neurostimulation, and the study compares different therapy approaches to evaluate their effects on migraine symptoms. The study is set to run from June 2024 to January 2029. During the study, participants will be monitored over 12 weeks to evaluate both safety and effectiveness. Researchers will assess clinical outcomes related to migraine treatment, with follow-ups as per study protocols. This period will involve treatment administration and regular evaluations to collect data on responses and any side effects experienced.