[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566132":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":10,"centralContacts":21,"locations":10,"responsibleParty":32,"collaborators":10,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":10,"enrollmentInfo":43,"targetDuration":10,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":10,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":10},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with clinical features consistent with erythrodermic cutaneous T cell lymphoma (CTCL)",null,"at initial diagnosis assessment",[13],"Other: Follow-up",{"label":15,"type":10,"description":10,"interventionNames":10},"Patients previously diagnosed with Sézary syndrome (SS) and followed at Saint-Louis hospital",[17],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"Follow-up","Clinical evaluation Blood sample Skin biopsy",[9],[22,28],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Hélène Moins, MD PhD","CONTACT","142499629","+33","helene.moins@u-paris.fr",{"name":29,"role":24,"phone":30,"phoneExt":26,"email":31},"Jérôme Lambert, MD PhD","142499742","jerome.lambert@u-paris.fr",{"type":33,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100566132","evaluation-of-the-kir3dl2-marker-in-flow-cytometry-for-szary-syndrome-diagnosis-therapeutic-response-and-residual-disease-a-prospective-and-multicenter-study-100566132",false,"NCT06651203","Evaluation of the KIR3DL2 Marker in Flow Cytometry for Sézary Syndrome Diagnosis, Therapeutic Response and Residual Disease: a Prospective and Multicenter Study","KISS01","Inclusion criteria for all patient :\n\n* Age ≥ 18\n* Patients with health insurance\n* Patients informed and not opposed to the study\n\nInclusion criteria for group 1 :\n\n\\- Patients with clinical features consistent with erythrodermic CTCL at initial diagnosis.\n\nInclusion criteria for group 2 :\n\n* Confirmed SS (previously diagnosed), followed at Saint Louis hospital participating center with all the following criteria:\n\n  1. Stage T4 erythroderma (stage (erythrodermia ≥ 80% of total body area)\n  2. The presence of an identical T-cell clone evidenced in blood and skin\n  3. B2 blood staging at initial diagnosis\n\n     Exclusion Criteria:\n* Other progressive neoplastic disease\n* Progressive psychotic disease\n* Patient under guardianship or curatorship\n* Patients with state medical aid\n* Refusal to participate","ALL","18 Years",{"count":44,"type":45},460,"ESTIMATED","OBSERVATIONAL","Cutaneous T-cell lymphomas (CTCL) are a group of primary cutaneous lymphomas including Mycosis Fungoides (MF) and Sézary syndrome (SS). SS is characterized by erythroderma and high numbers of circulating atypical lymphocytes (Sézary cells. SCs). Blood staging was added to the Tumor Node Metastasis (TNM) classification of MF\u002FSS, reflecting the broad spectrum of CTCLs and the poor prognosis related to blood involvement. Blood classes were defined using blood-smear manual counts. However, this method never reached an international consensus status because of its subjective nature and its poor sensitivity. Several markers have been identified with variable efficiency for MF\u002FSS diagnosis, outcome prediction and blood response to treatment. Such markers are essential for sharing and publishing consistent data about diagnosis, staging, prognosis and response to therapies. The detection of SCs is based on the lack of pan T-cell markers such as CD7 and\u002For CD26, which is not constant and may be observed in benign dermatoses. Thus, patients are often diagnosed with a delay, even treated with inappropriate therapies which worsens their prognosis. The relevance of blood-class in MF\u002FSS is not only related to stage but also contributes to the response to therapy in clinical trials. We found that a significant proportion of benign T-cells from SS patients are CD4+CD26-, which may underestimate the rate of complete response to treatment. The identification of KIR3DL2 on SCs by our team has greatly helped the detailed study of the malignant clone. We have recently published two ancillary studies demonstrating the specificity and reliability of KIR3DL2 as a positive marker for SCs, and its prognosis value at initial diagnosis. We have designed an optimized flow-cytometry strategy as part of the routine care of erythrodermic patients at Saint-Louis Hospital and published in 2019 the results of a 5 years prospective single-center study involving 254 CTCL patients at initial diagnosis. We provided recommendations with the use a threshold value of KIR3DL2+SCs ≥ 200\u002FµL or KIR3DL2+SCs\u002Flymphocytes ≥ 10% in the diagnostic criteria and proposed a novel algorithm blood staging.\n\nSeveral innovative immunotherapies in phase I\u002FII trials or under compassionate use are ongoing in French centers, with the need to assess blood response using positive markers. Our goal is to validate KIR3DL2 as a specific marker for SS and to assess its reliability for blood staging and response to treatment in a multicenter study (11 centers).",[49,50],"Mycosis Fungoides\u002FSezary Syndrome","Cutaneous T Cell Lymphoma","NOT_YET_RECRUITING","2024-10-18",{"date":54,"type":55},"2024-10-21","ACTUAL",{"date":57,"type":45},"2024-11-01",{"date":59,"type":45},"2029-11-01",{"name":5,"class":6}]