Clinical trial · Observational
Vascular Fingerprint Validation Study
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
NCT02573584CI-TRIAL-00077266completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Development of arterial cardiovascular events
- timeFrame
- first year after start of chemotherapy
- description
- 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 outcomes (3)
- measure
- Overall survival
- timeFrame
- first year after start of chemotherapy
- measure
- Response to testicular cancer treatment (no evidence of disease / relapse / no response to treatment)
- timeFrame
- first year after start of chemotherapy
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (10)
- RESULTEinhorn 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. PMID 71004
- RESULTDeSantis 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. PMID 24890451
- RESULTWeijl 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. PMID 10811682
- RESULTPiketty 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. PMID 16205699
- RESULTNuver 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. PMID 16301596
- RESULTDieckmann 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. PMID 22199322
- RESULTDieckmann 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.