Prolactinoma is a benign pituitary tumor that can influence hormone levels and overall health. Clinical trials for prolactinoma explore treatment evaluations aimed at controlling hormone secretion and tumor growth, along with monitoring approaches to...
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Found 19 Actively Recruiting clinical trials
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Researchers are investigating a new method to improve the accuracy of locating and diagnosing tiny breast duct lesions. This retrospective cohort study compares a novel fluorescent localization needle coated with a controllable shedding quantum dot chiral nanofluorescent layer against conventional localization techniques. The study focuses on how well this innovative needle helps pathologists identify small micro lesions in breast ducts, which are typically very challenging to detect due to their size. The study evaluates two groups: one where patients received breast duct excision surgery using the novel fluorescent localization marker needle, and another using conventional localization needles without any coating. During surgery, specimens are taken for frozen section analysis and later for detailed postoperative pathological evaluation using paraffin-embedded samples. This approach aims to compare the consistency between intraoperative and postoperative pathology results with both localization methods. Participants are female patients aged 18 to 75 years who have been diagnosed with intraductal breast lesions through ductoscopy and have undergone ductal excision. They will be monitored retrospectively, with pathological assessment concordance rates being the primary outcome measured from June to December 2025. The study will analyze how accurately each localization method helps in diagnosing breast duct micro lesions, potentially reducing missed diagnoses and the need for additional surgeries.
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Researchers are investigating a new fluorescent localization needle designed with a controllable shedding quantum dot chiral nanofluorescent coating to improve the accuracy of locating and diagnosing tiny microlesions in breast ducts. This prospective, multicenter cohort study compares this innovative needle to traditional localization methods used during breast duct lesion surgeries. The goal is to assess how well this new device helps pathologists make precise diagnoses and reduce missed lesions, which are challenging due to the small size of lesions and the narrow breast ducts. The study involves two groups of patients undergoing breast ductal excision surgery. One group will have surgery using the novel fluorescent localization needle, while the other group will have surgery using conventional localization needles without any special coating. This comparison aims to evaluate the real-time localization effectiveness and pathological accuracy between the two methods. The study is planned to start in January 2026 and will continue until September 2026. Participants will be monitored from enrollment through six weeks after treatment, with researchers measuring the agreement rates between intraoperative rapid pathology and postoperative pathology results. The trial includes various assessments to ensure accurate sampling and localization of microlesions. Safety and adherence to study protocols will also be monitored throughout the treatment period. The study is sponsored by The Fourth Affiliated Hospital of China Medical University and involves female patients aged 18 to 75 years scheduled for duct excision surgery.
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Researchers are evaluating pasireotide as a treatment for people with prolactinoma who cannot use dopamine agonist therapy. The study aims to assess whether pasireotide is effective and safe for these patients, focusing on those with intolerance, contraindications, or resistance to dopamine agonists. This is a Phase 2 interventional study sponsored by Memorial Sloan Kettering Cancer Center. All participants will begin open-label treatment with pasireotide long-acting release (LAR), starting with a 40 mg intramuscular dose in the first week. If tolerated, the dose will be increased to 60 mg every 4 weeks, with adjustments based on response and tolerability as judged by the investigator. Patients will return to the study center every 28 days (+/- 7 days) for medication administration and evaluation. Participants will be monitored through blood tests, tumor measurements, and patient questionnaires at baseline, week 12, 24, and 28. Researchers will track biochemical response within 24 weeks to measure treatment effect and radiographic response during the same period. Safety and tolerability assessments will be ongoing, and patients may continue treatment and follow-up as per study protocol until February 2027.
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Researchers are studying pituitary tumors, which are a varied group of tumors affecting the pituitary gland. This observational study focuses on collecting detailed clinical, biochemical, morphological, and pathological data from over 1600 patients who have undergone neurosurgical removal of pituitary tumors in the past 20 years. The goal is to develop a prognostic classification to better predict tumor behavior and outcomes, as current data on epidemiology and prognosis are inconclusive. The study involves patients who have had surgery for pituitary tumors, with data collected retrospectively and prospectively. The main focus is on monitoring the frequency of disease recurrence. Participants have been followed for at least two years after their tumor removal, allowing researchers to track tumor recurrence over time. Participants will be observed from enrollment through 24 months of follow-up to assess tumor recurrence. Researchers will gather information from medical records and follow-up visits to evaluate outcomes. This study does not involve any experimental treatment, but rather monitors surgical outcomes and tumor behavior to improve future understanding of pituitary tumors.
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Healthy Volunteer
Researchers are investigating tumors affecting the hypothalamic-pituitary unit in children and adults aged 2 to 70 years. The study aims to identify genetic factors involved in the development of these pituitary tumors and related disorders, as well as to develop new clinical studies for their recognition and treatment. It also explores the psychological effects of cortisol secretion in children with Cushing disease and seeks to understand inheritance patterns and associations with other family conditions. Participants undergo procedures including tissue specimen collection and MRI scans to study the molecular genetics of tumors and related developmental pathways. This observational protocol serves as a screening and training platform for medical fellows and students and supports the development of future clinical trials focused on diagnosis and therapy of pituitary tumors. During the study, participants provide peripheral blood and tumor tissue samples for molecular genetic testing. Researchers assess cognitive, psychological, and patient-reported health outcomes related to hypercortisolemia and adrenal insufficiency. The study also monitors clinical and genetic features of pituitary tumors and collects data on mental and social well-being. Participation involves ongoing assessments and follow-up to support future research and clinical care improvements.
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This research aims to validate the B-COMPASS, a computational model developed by the BEAMER project to improve patient adherence to treatment across various diseases. Adherence to treatment is a widespread issue leading to increased healthcare use and premature death, with about half of medications not taken as prescribed. The study evaluates the model's ability to predict adherence, identify patient support needs, and enhance healthcare engagement in six therapeutic areas, including cardiovascular, endocrinology, immunology, neurology, oncology, and rare diseases. Participants complete the BEAMER questionnaire, which the B-COMPASS uses to group patients based on their adherence needs and predict their adherence. Patients are randomized into a control group receiving standard care or an intervention group receiving enhanced engagement through educational materials for healthcare providers tailored to the patient's B-COMPASS profile. Engagement occurs in person or by phone, depending on patient schedules, and healthcare providers may also be randomized to limit knowledge of the B-COMPASS in control groups. Participants are involved in two main data collections spaced from 2 weeks to 6 months apart, during which adherence measures, patient support needs, and perceptions of engagement are assessed. The study measures the accuracy, validity, and reliability of B-COMPASS predictions, its impact on adherence, patient and provider perceptions, and cost-effectiveness. The total participation timeline varies by site and disease area, with continuous monitoring of healthcare utilization and patient experience.
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Researchers are studying patients with pituitary complex and rare diseases to better understand their clinical features and outcomes. This observational study at Peking Union Medical College Hospital aims to identify factors influencing remission rates, associated comorbidities, perioperative events, radiological findings, and pathological characteristics. By comparing different patient groups, the study seeks to improve knowledge about managing and predicting the course of these conditions. Participants include patients diagnosed with various pituitary disorders such as pituitary adenomas, craniopharyngiomas, Rathke's cleft cysts, sellar region germ cell tumors, and cavernous sinus syndrome. Those needing surgical removal or biopsy of pituitary pathologies will undergo transsphenoidal surgery or craniotomy. Treatments studied involve surgical removal and biopsy procedures to collect tissue for examination and diagnosis. During the study, participants will have detailed clinical evaluations, provide comprehensive medical histories including symptoms, treatments, and outcomes, and take part in follow-up assessments to monitor disease progression. Researchers will track remission starting one week after surgery and continuing up to three years, along with comorbidities and postoperative complications over the same period. The study collects imaging and pathological data to enhance understanding of these rare diseases.
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Researchers are conducting an observational, longitudinal study focused on patients with pituitary disorders who are followed at the Unit of Endocrinology of Azienda Ospedaliero-Universitaria of Modena. The study is designed to collect detailed clinical and epidemiological data to better understand this patient population over time. It includes both a retrospective phase and a prospective phase to capture comprehensive patient information. The study has two phases: the first phase involves retrospectively registering all patients with pituitary disorders treated at the center. The second phase prospectively enrolls patients attending the Unit of Endocrinology to gather ongoing data. Patients' personal information, details about their pituitary disease, symptoms, physical exams, imaging results, visual field data, and treatments including surgeries, hormone tests, and therapies will be collected and stored in an anonymized database. Participants will be involved through data collection from their medical records and ongoing clinical visits. Researchers will assess various clinical measures such as radiological imaging, hormone levels, and therapy management. The main outcome is to characterize pituitary patients over a 10-year period, along with studying their management. The study is expected to continue monitoring patients throughout this time frame to gain insights into pituitary disease progression and treatment.
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Healthy Volunteer
Neuroendocrine neoplasms (NENs) are a diverse group of tumors that arise from hormone-producing cells and can develop in various organs. Their behavior ranges from benign to aggressive, sometimes causing serious health problems due to excess hormone production. Many NENs are inherited or part of genetic syndromes, while others arise from non-inherited genetic changes. This research aims to identify genetic defects causing NENs in a large group of Mexican patients, improving understanding of their molecular causes and potential treatment targets. This study collects blood and tissue samples from adult patients with different types of NENs at two hospitals in Mexico City. Participants undergo genetic testing using three methods: targeted gene sequencing, analysis of gene copy number changes, and full exome sequencing in selected cases. The study also gathers detailed clinical, laboratory, imaging, and pathology information, and offers genetic screening to family members when appropriate. Samples and data are carefully stored and analyzed to detect genetic variants associated with NENs. Participants provide blood and, when possible, tumor tissue samples for DNA analysis. Researchers collect clinical and family history data, along with laboratory and imaging results. The main outcome is identifying genetic defects linked to NENs over a follow-up period of up to 15 years. Participants who want to know their genetic results receive detailed reports. The study seeks to correlate genetic findings with clinical features and outcomes, aiming to discover new genetic associations and improve future diagnosis and treatment strategies.
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Researchers are studying genes that may increase the risk of endocrine tumors, focusing primarily on pituitary adenomas such as growth hormone-secreting tumors (somatotrophinomas) and prolactinomas. The study aims to identify and understand the role of genes like AIP and related molecules in familial and sporadic pituitary tumors. The goal is to learn how these genes contribute to tumor development and to extend findings to other pituitary-related conditions. Participants will be recruited from endocrine clinics and other medical departments, especially those with inherited conditions indicated by early onset, multiple tumors, or affected family members. Blood samples and tumor tissue will be collected for genetic and protein studies. The research includes analysis of gene mutations, RNA expression, and protein levels using methods such as gene sequencing, RT-PCR, Western blotting, and immunohistochemistry. Participants will provide blood and, when applicable, tumor samples, which will be coded for privacy. Researchers will analyze these samples over a 10-year period for germline mutations and genetic markers. Family members may also be invited to participate to help identify inherited gene patterns. The study involves ongoing genetic assessments and monitoring to better understand endocrine tumor predisposition and gene function.
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