[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622730":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":33,"responsibleParty":49,"collaborators":25,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":25,"enrollmentInfo":60,"targetDuration":25,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":36,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MACS patients","EXPERIMENTAL","Analysis of the dynamics\u002Frhythmicity of interstitial cortisol and other steroid concentrations thanks to U-RHYTHM system, in MACS patients",[13],"Device: U-RYTHM system",{"label":15,"type":16,"description":17,"interventionNames":18},"ANS patients","ACTIVE_COMPARATOR","Analysis of the dynamics\u002Frhythmicity of interstitial cortisol and other steroid concentrations thanks to an original and innovative U-RHYTHM system, interstitial fluid samples, in ANS patients",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","U-RYTHM system","Consent will be obtained at inclusion. The patient will be seen by the investigating physician twice, 27 hours apart, for insertion and removal of the U-RHYTHM system. Microdialysis samples will be collected in the collection system. Samples will be directly frozen at -20°C or -80°C and transported at -20°C to the Ultradian Analysis Laboratory, Metabolomics Centre, Department of Clinical Sciences, University of Bergen, Norway, for sample preparation, LC-MSMS steroid profiling (panel of 21 steroids) and statistical analysis. The research protocol does not include patient follow-up.",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Amandine FERRIERE, Dr","CONTACT","05 57 57 64 24","+33","amandine.ferriere@chu-bordeaux.fr",[34],{"facility":35,"status":36,"city":37,"state":25,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hôpital Haut-Levêque","RECRUITING","Pessac","33600","France","FR",{"type":42,"coordinates":43},"Point",[44,45],-0.6324,44.80565,{"lat":45,"lon":44},[48],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"type":50,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100622730","ultradian-steroid-rhythms-in-adrenal-incidentalomas-100622730",false,"NCT07387419","Ultradian Steroid Rhythms in Adrenal Incidentalomas","CHRONOMACS","Inclusion Criteria:\n\n* 18 \\\u003C Age ≤ 85 years.\n* Patient with one or more uni or bilateral adrenal nodules of cortical appearance on CT scan.\n* Subject affiliated or beneficiary of a social security scheme.\n\nThe diagnostic criteria are:\n\nFor the MACS group:\n\n* a serum cortisol concentration after a minute braking test with dexamethasone \\> 50 nmol\u002FL or 1.8 µg\u002FdL, with a concomitant dexamethasone concentration above the test validation threshold\n* morning plasma ACTH concentration ≤ 2.5 pmol\u002FL or 11 pg\u002FmL.\n\nFor the non-secreting adenoma group:\n\n\\- Plasma cortisol after minute dexamethasone braking test ≤ 50 nmol\u002FL or 1.8 µg\u002FdL.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnant or breast-feeding\n* Use of oral estrogens (must be discontinued for at least 6 weeks prior to sampling)\n* Known adrenal insufficiency and\u002For treatment with steroids (oral, inhaled, parenteral or topical) or other interfering drugs.\n* patient taking part in another study\n* Patients placed under legal protection measures and\u002For deprived of their liberty","ALL","18 Years",{"count":61,"type":62},40,"ESTIMATED","INTERVENTIONAL",[65],"NA","Twenty to 40% of adrenal incidentalomas are responsible for MACS (mild autonomous cortisol producing secretion). The biological tools used in current practice to explore MACS do not provide precise information on cortisol production abnormalities. This study is a comparative analysis of the dynamics\u002Frhythmicity of interstitial cortisol and other steroid concentrations between MACS and non-secreting adenomas (ANS). Using the original and innovative U-RHYTHM system, interstitial fluid samples will be taken every 20 minutes for 24 to 48 hours from patients with MACS or non-secreting adenomas, and steroid assays will be performed in the perfusates to analyze steroid hormone production over 24 hours.",[68,69],"Mild Autonomous Cortisol Secretion Adenoma","Non Secreting Adenoma",[71,72,73],"Adrenal incidentaloma","Mild autonomous cortisol secretion adenoma","Ultradian steroid rhythms","2026-04-20",{"date":76,"type":77},"2026-04-23","ACTUAL",{"date":79,"type":77},"2026-04-15",{"date":81,"type":62},"2027-10",{"name":5,"class":6},1]