Vascular Fingerprint Validation Study

NCT02573584 | Completed

• 1 other identifier: 201500864
• Study Type: observational
• Target: 101
• Locations: 3 countries
• Sites: 5

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.

Conditions

Testicular Cancer

Outcome Measures

Primary Outcomes (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)

  first year after start of chemotherapy

Secondary Outcomes (3)

• Overall survival

  first year after start of chemotherapy

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

  first year after start of chemotherapy

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

  first year after start of chemotherapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Newly diagnosed testicular cancer patients before start of chemotherapy.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (5)

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

Amsterdam, Netherlands

Location

University Medical Center Groningen (UMCG)

Groningen, Netherlands

Location

Maastricht University Medical Center (MUMC)

Maastricht, Netherlands

Location

Instituto Portuges de Oncologia Francisco Gentil (IPOLFG)

Lisbon, Portugal

Location

UniversitatsSpital Zurich

Zurich, Switzerland

Location

Related Publications (10)

• 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.

  PMID: 71004 RESULT

• 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.

  PMID: 24890451 RESULT

• 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.

  PMID: 10811682 RESULT

• 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.

  PMID: 16205699 RESULT

• 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.

  PMID: 16301596 RESULT

• 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.

  PMID: 22199322 RESULT

• 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.

  PMID: 20067918 RESULT

• 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.

  PMID: 26240226 RESULT

• 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.

  PMID: 26304903 RESULT

• 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.

  PMID: 27322917 RESULT

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Jourik A Gietema, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 12, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3); PT (1); CH (1)