AzTrials
AzTrials

Testicular CancerNCT02573584

Vascular Fingerprint Validation Study

An observational study of Testicular Cancer, run by University Medical Center Groningen at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, men only
Conditions the study is for
Testicular Cancer
How many people
101 participants
Where
5 sitesin 3 countries
Study dates
1 Oct 2015to 1 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • No healthy volunteers
  • Adult

Study population: Newly diagnosed testicular cancer patients before start of chemotherapy.

Who may be able to join

  • Diagnosis of metastatic TC and an indication to start with first-line cisplatin-based chemotherapy for metastatic TC
  • Classified into IGCCCG good or intermediate prognosis group
  • Younger than 50 years of age at start of chemotherapy
  • Signed informed consent

Who cannot join

  • History of previous cardiovascular disease
  • Retroperitoneal mass > 5 cm
  • Indication for anticoagulant therapy at start of chemotherapy

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Netherlands3 sites

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek ziekenhuis (NKI-AVL)

    Amsterdam

  • University Medical Center Groningen (UMCG)

    Groningen

  • Maastricht University Medical Center (MUMC)

    Maastricht

Other trials in Netherlands

Portugal1 site

  • Instituto Portuges de Oncologia Francisco Gentil (IPOLFG)

    Lisbon

Other trials in Portugal

Switzerland1 site

  • UniversitatsSpital Zurich

    Zurich

Other trials in Switzerland

About this study

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

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.

Read the 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.

Medical subject headings
Testicular Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of arterial cardiovascular events

    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)

    Measured: first year after start of chemotherapy

Secondary outcomes (3)

  1. Overall survival

    Measured: first year after start of chemotherapy

  2. Response to testicular cancer treatment (no evidence of disease / relapse / no response to treatment)

    Measured: first year after start of chemotherapy

  3. Development of venous thromboembolic events (VTE) (WHO ICD-10 I26, I80-82)

    Measured: first year after start of chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2015 (estimated)
  2. Study start1 Oct 2015
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02573584
Sponsor's protocol ID
201500864
Status last verified
May 2024
First submitted
8 Oct 2015
Last updated
17 May 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Einhorn LH, Donohue J. Cis-diamminedichloroplatinum, vinblastine, and bleomycin combination chemotherapy in disseminated testicular cancer. Ann Intern Med. 1977 Sep;87(3):293-8. doi: 10.7326/0003-4819-87-3-293.

    PubMed 71004

  • DeSantis CE, Lin CC, Mariotto AB, Siegel RL, Stein KD, Kramer JL, Alteri R, Robbins AS, Jemal A. Cancer treatment and survivorship statistics, 2014. CA Cancer J Clin. 2014 Jul-Aug;64(4):252-71. doi: 10.3322/caac.21235. Epub 2014 Jun 1.

    PubMed 24890451

  • Weijl NI, Rutten MF, Zwinderman AH, Keizer HJ, Nooy MA, Rosendaal FR, Cleton FJ, Osanto S. Thromboembolic events during chemotherapy for germ cell cancer: a cohort study and review of the literature. J Clin Oncol. 2000 May;18(10):2169-78. doi: 10.1200/JCO.2000.18.10.2169.

    PubMed 10811682

  • Piketty AC, Flechon A, Laplanche A, Nouyrigat E, Droz JP, Theodore C, Fizazi K. The risk of thrombo-embolic events is increased in patients with germ-cell tumours and can be predicted by serum lactate dehydrogenase and body surface area. Br J Cancer. 2005 Oct 17;93(8):909-14. doi: 10.1038/sj.bjc.6602791.

    PubMed 16205699

  • Nuver J, Smit AJ, van der Meer J, van den Berg MP, van der Graaf WT, Meinardi MT, Sleijfer DT, Hoekstra HJ, van Gessel AI, van Roon AM, Gietema JA. Acute chemotherapy-induced cardiovascular changes in patients with testicular cancer. J Clin Oncol. 2005 Dec 20;23(36):9130-7. doi: 10.1200/JCO.2005.01.4092. Epub 2005 Nov 21.

    PubMed 16301596

  • Dieckmann KP, Struss WJ, Budde U. Evidence for acute vascular toxicity of cisplatin-based chemotherapy in patients with germ cell tumour. Anticancer Res. 2011 Dec;31(12):4501-5.

    PubMed 22199322

  • Dieckmann KP, Gerl A, Witt J, Hartmann JT; German Testicular Cancer Study Group. Myocardial infarction and other major vascular events during chemotherapy for testicular cancer. Ann Oncol. 2010 Aug;21(8):1607-1611. doi: 10.1093/annonc/mdp597. Epub 2010 Jan 12.

    PubMed 20067918

  • Fung C, Fossa SD, Milano MT, Sahasrabudhe DM, Peterson DR, Travis LB. Cardiovascular Disease Mortality After Chemotherapy or Surgery for Testicular Nonseminoma: A Population-Based Study. J Clin Oncol. 2015 Oct 1;33(28):3105-15. doi: 10.1200/JCO.2014.60.3654. Epub 2015 Aug 3.

    PubMed 26240226

  • Ramos JD, Yu EY. Cardiovascular Mortality in Testicular Nonseminomatous Germ Cell Tumors: Does Statistical Significance Imply Clinical Significance? J Clin Oncol. 2015 Oct 1;33(28):3075-7. doi: 10.1200/JCO.2015.62.7398. Epub 2015 Aug 24. No abstract available.

    PubMed 26304903

  • Lubberts S, Boer H, Altena R, Meijer C, van Roon AM, Zwart N, Oosting SF, Kamphuisen PW, Nuver J, Smit AJ, Mulder AB, Lefrandt JD, Gietema JA. Vascular fingerprint and vascular damage markers associated with vascular events in testicular cancer patients during and after chemotherapy. Eur J Cancer. 2016 Aug;63:180-8. doi: 10.1016/j.ejca.2016.05.022. Epub 2016 Jun 17.

    PubMed 27322917

Questions about this trial

What is this clinical trial studying?

An observational study of Testicular Cancer, run by University Medical Center Groningen at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands, Portugal, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of arterial cardiovascular events (time frame: first year after start of chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02573584, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.

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