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Vascular Fingerprint Validation Study

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ClinicalTrials.gov Identifier: NCT02573584
Recruitment Status : Recruiting
First Posted : October 12, 2015
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
J.A. Gietema, University Medical Center Groningen

Brief Summary:
The vascular fingerprint is a simple selection tool to identify testicular cancer patients with a high risk of arterial cardiovascular events during and in the first year after cisplatin chemotherapy. Eventually, this selection method allows a relative small randomized intervention study with i.e. LMWH during chemotherapy to prove the effectiveness and safety in lowering the chance of an arterial cardiovascular event.

Condition or disease
Testicular Cancer

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.

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Study Type : Observational
Estimated Enrollment : 178 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Fingerprint to Identify Patients at Risk for Arterial Cardiovascular Events Within the First Year After Start of Cisplatin-based Chemotherapy for Testicular Cancer: a Validation Study
Study Start Date : October 2015
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly diagnosed testicular cancer patients before start of chemotherapy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573584


Contacts
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Contact: Jourik A Gietema, MD, PhD +31 503616161 j.a.gietema@umcg.nl
Contact: Sjoukje Lubberts, MD +31 503616161 s.lubberts@umcg.nl

Locations
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Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek ziekenhuis (NKI-AVL) Recruiting
Amsterdam, Netherlands
Contact: J. Kerst, MD PhD         
University Medical Center Groningen (UMCG) Recruiting
Groningen, Netherlands
Contact: J.A. Gietema, MD PhD       j.a.gietema@umcg.nl   
Contact: S. Lubberts, MD       s.lubberts@umcg.nl   
Maastricht University Medical Center (MUMC) Recruiting
Maastricht, Netherlands
Contact: M. Aarts, MD PhD         
Portugal
Instituto Portuges de Oncologia Francisco Gentil (IPOLFG) Recruiting
Lisbon, Portugal
Contact: M. Brito, MD PhD         
Switzerland
UniversitatsSpital Zurich Recruiting
Zurich, Switzerland
Contact: J. Beyer, MD PhD         
Contact: C. Fankhauser, MD PhD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Jourik A Gietema, MD, PhD University Medical Center Groningen
Publications of Results:

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Responsible Party: J.A. Gietema, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02573584    
Other Study ID Numbers: 201500864
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders