Vascular Fingerprint Validation Study

May 16, 2024 updated by: University Medical Center Groningen

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
      • Groningen, Netherlands
        • University Medical Center Groningen (UMCG)
      • Maastricht, Netherlands
        • Maastricht University Medical Center (MUMC)
  • Portugal
      • Lisbon, Portugal
        • Instituto Portuges de Oncologia Francisco Gentil (IPOLFG)
  • Switzerland
      • Zurich, Switzerland
        • Universitatsspital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Newly diagnosed testicular cancer patients before start of chemotherapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
first year after start of chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: first year after start of chemotherapy
first year after start of chemotherapy
Response to testicular cancer treatment (no evidence of disease / relapse / no response to treatment)
Time Frame: first year after start of chemotherapy
first year after start of chemotherapy
Development of venous thromboembolic events (VTE) (WHO ICD-10 I26, I80-82)
Time Frame: first year after start of chemotherapy
first year after start of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimated)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201500864

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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