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NOT YET RECRUITING
NCT07684066

D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab

Sponsor: Universitätsklinikum Hamburg-Eppendorf

View on ClinicalTrials.gov

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

Interventions

OTHER

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