[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500527":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":10,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Sebaceous carcinoma",null,"patients with sebaceous carcinoma both primary and relapsed after surgical and\u002For radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS",[13],"Procedure: Sentinel Lymph Node Biopsy",{"label":15,"type":10,"description":16,"interventionNames":17},"Merkel's carcinoma","patients with Merkel's carcinoma both primary and relapsed after surgical and\u002For radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Porocarcinoma","patients with Porocarcinoma both primary and relapsed after surgical and\u002For radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Conjunctival Melanoma","patients with Conjunctival Melanoma both primary and relapsed after surgical and\u002For radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Squamous cell Carcinoma","patients with squamous cell Carcinoma of the ocular surface and adnexa both primary and relapsed after surgical and\u002For radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"PROCEDURE","Sentinel Lymph Node Biopsy","* Injection of 99mTc-labeled nanocolloids\n* Preoperative lymphoscintigraphy\n* Intraoperative gamma probe search of the sentinel lymph node\n* Sentinel lymph node biopsy\n* Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.\n* If the SLN is histologically positive, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and\u002For adjuvant radio\u002Fchemotherapy.",[23,15,19,9,27],[37],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Gustavo Savino, MD","CONTACT","0630154528","oncologiaoculare@policlinicogemelli.it",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Gustavo Savino","RECRUITING","Roma","Rome","00168","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],11.10642,44.99364,{"lat":55,"lon":54},[58],{"name":38,"role":39,"phone":59,"phoneExt":10,"email":41},"+390630154528",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Savino Gustavo","Professor","100500527","sentinel-lymph-node-biopsy-in-ocular-surface-and-adnexal-cancers-100500527",false,"NCT05797415","Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers","Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study","BLS","Inclusion Criteria:\n\n* All patients with Porocarcinoma, Ca of Merkel, Ca Sebaceous\n* Patients with cutaneous adnexal melanoma with thickness ≥1.5 mm, Clark's level ≥3, \\>1 mitotic figure per high-power field.\n* Patients with conjunctival melanoma both primary and recurrent and associated with primary acquired melanosis with atypia.\n* Patients with squamous cell Ca of adnexa with Staging ≥3, locally recurrent or with perineural invasion\n* Patients with squamous cell Ca of the surface with Staging ≥3 and\u002For multicenter\n* Signature of informed consent to participate in the study\n* cNo\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Patients with metastatic disease at diagnosis\n* All patients who do not fit the inclusion criteria\n* Failure to obtain informed consent","ALL","18 Years","95 Years",{"count":76,"type":77},25,"ESTIMATED","OBSERVATIONAL","The study involves enrollment of patients with sebaceous carcinoma, Merkel's carcinoma, Porocarcinoma, Melanoma, and squamous cell Ca of the ocular surface and adnexa both primary and relapsed after surgical and\u002For radiation-chemotherapy treatment at the Fondazione Policlinico Universitario A. Gemelli, IRCCS. The study will last 9 years: 1 year will be devoted to the first phase of the study. Patient enrollment will continue for an additional 3 years, and 5 years will be devoted overall to patient follow-up so that survival outcomes at 1-3 and 5 years can be assessed in a congruent number of patients. A preliminary analysis of the data at 1 year (pilot phase), an analysis at 4 years to confirm the preliminary study data on a larger sample, and a final analysis to evaluate OS and PFS at the 3 time-points indicated are planned.",[81,82,83,84,19,23],"Ocular Sebaceous Carcinoma","Ocular Basal Cell Carcinoma","Ocular Surface Squamous Neoplasia","Merkel Cell Carcinoma, Unspecified",[33,86,87],"Malignant ocular surface tumors","Malignant eyelids tumors","2024-09-27",{"date":90,"type":91},"2024-10-01","ACTUAL",{"date":93,"type":91},"2023-03-01",{"date":95,"type":77},"2032-03-15",{"name":5,"class":6},1]