- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07684066
D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab (D-TECT)
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 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.
연구 개요
상태
개입 / 치료
상세 설명
Cutaneous squamous cell carcinoma (cSCC) is one of the most common skin cancers. While most cases can be treated with curative local therapy, a subgroup of patients develops locally advanced or metastatic disease requiring systemic treatment. Cemiplimab, a PD-1 inhibitor, is an established systemic treatment option for advanced cSCC. However, validated routine biomarkers predicting disease control under cemiplimab are lacking.
D-dimers are fibrin degradation products and sensitive markers of coagulation activation. In a prior single-center retrospective analysis, elevated pretreatment D-dimer levels were associated with lower disease control, lower objective response, and shorter progression-free survival in patients with advanced cSCC treated with cemiplimab. D-TECT is designed to prospectively validate this observation in a multicenter real-world cohort.
Eligible patients are adults with histologically confirmed locally advanced or metastatic cSCC for whom cemiplimab treatment is planned as part of routine clinical care. A D-dimer measurement is documented within 7 days before the first cemiplimab dose up to the day of first administration before infusion. Subsequent clinical data, including tumor response, progression, survival, treatment discontinuation, and thromboembolic events, are collected from routine medical records during follow-up.
The primary endpoint is disease control within the first 6 months after initiation of cemiplimab. The primary confirmatory analysis compares disease control between patients with high versus low pretreatment D-dimer values using the prespecified cutoff of 0.91 mg/L FEU derived from the prior single-center study. If the primary analysis is statistically significant, the same primary endpoint will be tested hierarchically using the local laboratory-defined upper limit of normal. Additional analyses include objective response rate, progression-free survival, overall survival, thromboembolic events, diagnostic performance measures of the predefined cutoffs, sensitivity analyses, and exploratory analyses addressing inter-site assay heterogeneity.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Glenn Geidel, MD, MSc
- 전화번호: +49 (0)40 7410 70743
- 이메일: g.geidel@uke.de
연구 장소
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Bielefeld, 독일, 33647
- University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe
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연락하다:
- Selma Ugurel, MD
- 전화번호: +49 (0)521 9438801
- 이메일: selma.ugurel@klinikumbielefeld.de
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수석 연구원:
- Selma Ugurel, MD
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Bremerhaven, 독일, 27574
- Klinikum Bremerhaven Reinkenheide
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연락하다:
- Michael M. Sachse, MD
- 전화번호: +49 (0)471 2993700
- 이메일: Michael.Sachse@klinikum-bremerhaven.de
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수석 연구원:
- Michael M. Sachse, MD
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Buxtehude, 독일, 21614
- Elbe Klinikum Buxtehude
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연락하다:
- Kai-Martin Thoms, MD
- 전화번호: +49 (0)4161 7036250
- 이메일: kai-martin.thoms@elbekliniken.de
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수석 연구원:
- Kai-Martin Thoms, MD
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Erlangen, 독일, 91054
- University Medical Center Erlangen
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연락하다:
- Markus V. Heppt, MD, PhD, MHBA
- 전화번호: +49 (0)9131 8533165
- 이메일: onkstudienzentrale.DE@uk-erlangen.de
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수석 연구원:
- Markus V. Heppt, MD, PhD, MHBA
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Göttingen, 독일, 37075
- University Medical Center Göttingen
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연락하다:
- Katharina Amschler, MD
- 전화번호: +49 (0)551 3968082
- 이메일: katharina.amschler@med.uni-goettingen.de
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수석 연구원:
- Katharina Amschler, MD
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Hamburg, 독일, 20246
- University Medical Center Hamburg-Eppendorf
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연락하다:
- Glenn Geidel, MD, MSc
- 전화번호: +49 (0)40 741070743
- 이메일: g.geidel@uke.de
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수석 연구원:
- Glenn Geidel, MD, MSc
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Hanover, 독일, 30625
- Hannover Medical School
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연락하다:
- Imke von Wasielewski, MD
- 전화번호: +49 (0)5115320
- 이메일: vonWasielewski.Imke@mh-hannover.de
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수석 연구원:
- Imke von Wasielewski, MD
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Kiel, 독일, 24105
- University Medical Center Schleswig-Holstein, Campus Kiel
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수석 연구원:
- Katharina Kähler, MD
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연락하다:
- Katharina Kähler, MD
- 전화번호: +49 (0)431 50021131
- 이메일: Katharina.Kaehler@uksh.de
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Lübeck, 독일, 23538
- University Medical Center Schleswig-Holstein, Campus Lübeck
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연락하다:
- Dagmar von Bubnoff, MD
- 전화번호: +49 (0)451 50041501
- 이메일: DagmarAngela.vonbubnoff@uksh.de
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수석 연구원:
- Dagmar von Bubnoff, MD
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Mainz, 독일, 55131
- University Medical Center Mainz
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연락하다:
- Henner Stege, MD
- 전화번호: +49 (0)6131 172919
- 이메일: Henner.Stege@unimedizin-mainz.de
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수석 연구원:
- Henner Stege, MD
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Mannheim, 독일, 68167
- University Medical Center Mannheim
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수석 연구원:
- Jochen Utikal, MD
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연락하다:
- Jochen Utikal, MD
- 전화번호: +49 (0)621 3834461
- 이메일: jochen.utikal@umm.de
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Minden, 독일, 32429
- Johannes Wesling Klinikum Minden
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연락하다:
- Ralf Gutzmer, MD
- 전화번호: +49 (0)571 7904501
- 이메일: dermatologie-minden@muehlenkreiskliniken.de
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수석 연구원:
- Ralf Gutzmer, MD
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Rostock, 독일, 18057
- University Medical Center Rostock
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연락하다:
- Markus Thieme, MD
- 전화번호: +49 (0) 381 494 9789
- 이메일: Markus.Thieme@med.uni-rostock.de
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수석 연구원:
- Markus Thieme, MD
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Tübingen, 독일, 72076
- University Medical Center Tübingen
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수석 연구원:
- Ulrike Leiter, MD
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연락하다:
- Ulrike Leiter, MD
- 전화번호: +49 (0)7071 2984555
- 이메일: ulrike.leiter@med.uni-tuebingen.de
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Salzburg, 오스트리아, 5020
- University Medical Center Salzburg
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연락하다:
- Matthias Brandlmaier, MD, PhD, MSc
- 전화번호: +43 (0) 57255 24601
- 이메일: m.brandlmaier@salk.at
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수석 연구원:
- Matthias Brandlmaier, MD, PhD, MSc
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma
- Planned initiation of systemic treatment with cemiplimab as part of routine clinical care
- Pretreatment D-dimer measurement performed within 7 days before initiation of cemiplimab treatment up to the day of first administration before infusion
- Age 18 years or older at the time of consent
- ECOG performance status 0 to 2
- Written informed consent for study participation and pseudonymized collection and analysis of clinical and laboratory data
Exclusion Criteria:
- Prior treatment with immune checkpoint inhibitors in curative or palliative intent for cutaneous squamous cell carcinoma
- Concurrent second malignancy requiring systemic treatment, such as chemotherapy, immunotherapy, or targeted therapy
- Clinically unstable comorbidity, including NYHA class III-IV heart failure or active systemic infection
- Acute symptomatic thrombosis or pulmonary embolism within 4 weeks before the pretreatment D-dimer measurement
- 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
- 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
- Lack of capacity to consent or legal guardianship without valid legal representation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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High pretreatment D-dimer
Patients with locally advanced or metastatic cutaneous squamous cell carcinoma treated with cemiplimab in routine clinical care and a pretreatment D-dimer level above the prespecified cutoff of 0.91 mg/L FEU.
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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.
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Low pretreatment D-dimer
Patients with locally advanced or metastatic cutaneous squamous cell carcinoma treated with cemiplimab in routine clinical care and a pretreatment D-dimer level at or below the prespecified cutoff of 0.91 mg/L FEU.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
기간: From start of cemiplimab treatment through 6 months
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Disease control rate is defined as the proportion of participants with complete response, partial response, or stable disease according to clinical and/or radiological assessment in routine care within the first 6 months after initiation of cemiplimab.
Participants with documented progression, death, or treatment discontinuation due to clinical progression within the first 6 months are considered not to have disease control.
Participants without documented progression or death but without evaluable clinical or radiological follow-up assessment within the first 6 months are considered not evaluable for the primary analysis.
The primary confirmatory analysis compares disease control between participants with high versus low pretreatment D-dimer levels using the prespecified cutoff of 0.91 mg/L FEU.
If statistically significant, the same primary endpoint will be tested hierarchically using the local laboratory-defined upper limit of normal.
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From start of cemiplimab treatment through 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response Rate
기간: From start of cemiplimab treatment through 24 months
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Objective response rate is defined as the proportion of participants with complete response or partial response according to clinical and/or radiological assessment in routine care during follow-up.
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From start of cemiplimab treatment through 24 months
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Progression-Free Survival
기간: From start of cemiplimab treatment through 24 months
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Progression-free survival is defined as the time from initiation of cemiplimab treatment to the first documented disease progression or death from any cause, whichever occurs first.
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From start of cemiplimab treatment through 24 months
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Overall Survival
기간: From start of cemiplimab treatment through 24 months
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Overall survival is defined as the time from initiation of cemiplimab treatment to death from any cause.
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From start of cemiplimab treatment through 24 months
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Thromboembolic Events During Follow-up
기간: From start of cemiplimab treatment through 24 months
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Incidence of venous or arterial thromboembolic events documented during follow-up and evaluated in relation to pretreatment D-dimer levels.
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From start of cemiplimab treatment through 24 months
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Diagnostic Performance of Prespecified D-dimer Cutoffs for 6-Month Disease Control
기간: From start of cemiplimab treatment through 6 months
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Sensitivity, specificity, positive predictive value, and negative predictive value of the prespecified D-dimer cutoff of 0.91 mg/L FEU and of the local laboratory-defined upper limit of normal for disease control within the first 6 months after initiation of cemiplimab.
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From start of cemiplimab treatment through 6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative Incidence of Documented Disease Progression Accounting for Death as a Competing Event
기간: From start of cemiplimab treatment through 24 months
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Exploratory competing-risk analysis of the cumulative incidence of documented disease progression, treating death without prior documented progression as a competing event.
Deaths without prior documented progression will additionally be described by cause of death where available from the medical record.
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From start of cemiplimab treatment through 24 months
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Association of Pretreatment D-dimer Levels With Clinical Outcomes in Multivariable Models
기간: From start of cemiplimab treatment through 24 months
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Exploratory multivariable models evaluating the association between pretreatment D-dimer levels and clinical outcomes while accounting for predefined clinical covariates such as performance status, lactate dehydrogenase, comorbidities, and anticoagulation.
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From start of cemiplimab treatment through 24 months
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Exploratory Analysis of Assay-Related Heterogeneity in D-dimer Measurements
기간: Baseline through 24 months
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Exploratory evaluation of inter-site heterogeneity in D-dimer assays, measurement units, and local reference ranges.
Analyses may include ULN-normalized D-dimer values defined as the quotient of the measured value and the local upper limit of normal.
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Baseline through 24 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Glenn Geidel, MD, MSc, Universitätsklinikum Hamburg-Eppendorf
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- D-TECT
- DRKS00040746 (레지스트리 식별자: German Clinical Trials Register)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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