JOURNAL ONKOLOGIE – STUDIE

Vascular Fingerprint Validation Study

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT02573584

Studienbeginn:
Oktober 2015

Letztes Update:
24.05.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Testicular Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Medical Center Groningen

Collaborator:
-

Studienleiter

Jourik A Gietema, MD, PhD
Principal Investigator
University Medical Center Groningen

Kontakt

Jourik A Gietema, MD, PhD
Kontakt:
Phone: +31 503616161
E-Mail: j.a.gietema@umcg.nl» Kontaktdaten anzeigen

Sjoukje Lubberts, MD
Kontakt:
Phone: +31 503616161
E-Mail: s.lubberts@umcg.nl» Kontaktdaten anzeigen

Studienlocations
(3 von 5)

Nederlands Kanker Instituut - Antoni van Leeuwenhoek ziekenhuis (NKI-AVL)
Amsterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
J. Kerst, MD PhD» Ansprechpartner anzeigen

University Medical Center Groningen (UMCG)
Groningen
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
J.A. Gietema, MD PhD
E-Mail: j.a.gietema@umcg.nl

S. Lubberts, MD
E-Mail: s.lubberts@umcg.nl» Ansprechpartner anzeigen

Maastricht University Medical Center (MUMC)
Maastricht
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
M. Aarts, MD PhD» Ansprechpartner anzeigen

Instituto Portuges de Oncologia Francisco Gentil (IPOLFG)
Lisbon
PortugalRekrutierend» Google-Maps
Ansprechpartner:
M. Brito, MD PhD» Ansprechpartner anzeigen

UniversitatsSpital Zurich
Zurich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
J. Beyer, MD PhD

C. Fankhauser, MD PhD» Ansprechpartner anzeigen

Alle anzeigen

Studien-Informationen

Detailed Description:

Since the introduction of cisplatin in the late seventies (1), the prognosis of metastatic

testicular cancer patients has dramatically improved, with long-term survival rates of 80-90%

(2). However, cure rates are compromised by the increased risk of cardiovascular events

(3-5). Approximately 1-5% of the patients with metastatic testicular cancer develop arterial

cardiovascular events during or shortly after cisplatin- and bleomycin containing

chemotherapy (3-7). Arterial cardiovascular events include ischemic stroke and myocardial

infarction. These arterial events are a source of serious treatment-induced morbidity and

mortality as recently clearly confirmed by Fung (8). No established standard prophylaxis is

available. There is an unmet need to have the possibility to identify high risk patients

before start of chemotherapy in whom prophylactic anti-coagulant treatment may prevent events

(9). An identification tool could maximize the benefit of an intervention without introducing

too much unnecessary harm: preventive interventions also carry risk.

Recent data from the investigators' cancer center showed that before chemotherapy 22% of the

metastatic cancer patients had ≥3 of the following 5 traditional cardiovascular risk factors

present (high risk vascular fingerprint, figure 1): overweight, smoking, hypertension,

dyslipidemia and impaired blood glucose. These patients had an increased risk to develop

arterial events during or early after chemotherapy: 19% of the patients with a high risk

vascular fingerprint developed an arterial cardiovascular event whereas only 2% of the

patients with ≤2 risk factors developed an event . The vascular fingerprint seems an easy

method to identify which metastatic testicular cancer patients are at a high risk for early

arterial events and who may benefit from prophylaxis with for example low molecular weight

heparins (LMWHs). To be used in the clinic these data need to be confirmed in an independent

cohort.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Diagnosis of metastatic TC and an indication to start with first-line cisplatin-based

chemotherapy for metastatic TC

2. Classified into IGCCCG good or intermediate prognosis group

3. Younger than 50 years of age at start of chemotherapy

4. Signed informed consent

Exclusion Criteria:

1. History of previous cardiovascular disease

2. Retroperitoneal mass > 5 cm

3. Indication for anticoagulant therapy at start of chemotherapy

Studien-Rationale

Primary outcome:

1. Development of arterial cardiovascular events (Time Frame - first year after start of chemotherapy):
Primary outcome is development of arterial cardiovascular events within the first year after start of chemotherapy. Events taken into account are: myocardial infarction (WHO ICD-10 I20-I25), ischemic cerebrovascular accidents (WHO ICD-10 I63-I66 and G45) or infarction in other specific organ systems (WHO ICD-10 K76.3, K55, D73.5, M62.2, N28.0)

Secondary outcome:

1. Overall survival (Time Frame - first year after start of chemotherapy)

2. Response to testicular cancer treatment (no evidence of disease / relapse / no response to treatment) (Time Frame - first year after start of chemotherapy)

3. Development of venous thromboembolic events (VTE) (WHO ICD-10 I26, I80-82) (Time Frame - first year after start of chemotherapy)

Quelle: ClinicalTrials.gov

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