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2984555","ulrike.leiter@med.uni-tuebingen.de",{"name":257,"role":26,"phone":10,"phoneExt":10,"email":10},{"type":262,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100647047","d-tect-pretreatment-d-dimers-and-disease-control-in-advanced-cscc-treated-with-cemiplimab-100647047",false,"NCT07684066","D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab","D-TECT: Prospective Multicenter Evaluation of Pretreatment D-dimer Levels as a Predictor of Disease Control in Advanced Cutaneous Squamous Cell Carcinoma Treated With Cemiplimab","D-TECT","Inclusion Criteria:\n\n* Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma\n* Planned initiation of systemic treatment with cemiplimab as part of routine clinical care\n* Pretreatment D-dimer measurement performed within 7 days before initiation of cemiplimab treatment up to the day of first administration before infusion\n* Age 18 years or older at the time of consent\n* ECOG performance status 0 to 2\n* Written informed consent for study participation and pseudonymized collection and analysis of clinical and laboratory data\n\nExclusion Criteria:\n\n* Prior treatment with immune checkpoint inhibitors in curative or palliative intent for cutaneous squamous cell carcinoma\n* Concurrent second malignancy requiring systemic treatment, such as chemotherapy, immunotherapy, or targeted therapy\n* Clinically unstable comorbidity, including NYHA class III-IV heart failure or active systemic infection\n* Acute symptomatic thrombosis or pulmonary embolism within 4 weeks before the pretreatment D-dimer measurement\n* Incidental asymptomatic thromboembolic events detected during clinical diagnostic work-up or following an elevated D-dimer result are not exclusion criteria and will be documented\n* Physician-estimated life expectancy of less than 3 months or severe non-tumor-related comorbidity likely to preclude assessment of the clinical course within the first 6 months\n* Lack of capacity to consent or legal guardianship without valid legal representation","ALL","18 Years",{"count":274,"type":275},116,"ESTIMATED","OBSERVATIONAL","D-TECT is a prospective, multicenter, non-interventional observational study investigating whether pretreatment D-dimer levels predict disease control in patients with locally advanced or metastatic cutaneous squamous cell carcinoma treated with cemiplimab in routine clinical care.\n\nD-dimers are routinely available laboratory markers related to activation of the coagulation system. Previous single-center data suggest that elevated pretreatment D-dimer levels may be associated with poorer disease control under cemiplimab. In D-TECT, a single pretreatment D-dimer value and prospectively collected routine clinical follow-up data will be analyzed to validate this association in a multicenter real-world setting. No study-specific treatment decisions, imaging procedures, or additional blood draws are mandated by the study.",[279,280,281],"Cutaneous Squamous Cell Carcinoma (CSCC)","Advanced Cutaneous Squamous Cell Carcinoma","Metastatic Cutaneous Squamous Cell Carcinoma",[283,284,285,286,287,288,289,290,291,292],"CSCC","Cutaneous Squamous Cell Carcinoma","D-Dimer","Cemiplimab","PD-1 inhibitor","immunotherapy","biomarker","disease control","coagulation","real-word evidence","NOT_YET_RECRUITING","2026-07-21",{"date":296,"type":297},"2026-07-22","ACTUAL",{"date":299,"type":275},"2026-08-01",{"date":301,"type":275},"2030-03-31",{"name":5,"class":6},15]