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D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Summary
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. D-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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
116
Start Date
2026-08-01
Completion Date
2030-03-31
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
Pretreatment D-dimer status
Pretreatment D-dimer status is defined using a single D-dimer measurement obtained in routine clinical laboratory testing within 7 days before the first cemiplimab dose up to the day of first administration before infusion. D-dimer status is not used to assign treatment and does not mandate any study-specific diagnostic or therapeutic intervention.
Locations (14)
University Medical Center Salzburg
Salzburg, Austria
University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe
Bielefeld, Germany
Klinikum Bremerhaven Reinkenheide
Bremerhaven, Germany
Elbe Klinikum Buxtehude
Buxtehude, Germany
University Medical Center Erlangen
Erlangen, Germany
University Medical Center Göttingen
Göttingen, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Hannover Medical School
Hanover, Germany
University Medical Center Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
University Medical Center Mainz
Mainz, Germany
University Medical Center Mannheim
Mannheim, Germany
Johannes Wesling Klinikum Minden
Minden, Germany
University Medical Center Rostock
Rostock, Germany
University Medical Center Tübingen
Tübingen, Germany