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Markers for Acute Chemotherapy induced Cardiovascular changes.


- candidate number2097
- NTR NumberNTR686
- ISRCTNISRCTN54551960
- Date ISRCTN created19-jul-2006
- date ISRCTN requested4-jul-2006
- Date Registered NTR19-mei-2006
- Secondary IDsN/A 
- Public TitleMarkers for Acute Chemotherapy induced Cardiovascular changes.
- Scientific TitleEvaluation of markers for cardiovascular changes during and after cisplatin based chemotherapy in patients with testicular cancer.
- ACRONYMMACC1
- hypothesis1. The number of circulating endothelial (progenitor) cells may be reduced during chemotherapy and correlate to the development of cardiovascular disease; 2. Oxidative stress due to chemotherapy may lead to an increased accumulation of Advanced Glycation End products (AGEs) in blood vessels, contributing to endothelial damage.
- Healt Condition(s) or Problem(s) studiedTesticular cancer
- Inclusion criteria1. Patients with disseminated testicular cancer who will be treated with cisplatin based chemotherapy; 2. Age 18-50 years at start of treatment; 3. Written informed consent.
- Exclusion criteria1. Medical history of cardiovascular disease; 2. Known renal disease or estimated glomerular filtration rate (GFR) < 60 ml/min (using Cockcroft-Gault formula).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type-
- Studytypeintervention
- planned startdate 16-mei-2006
- planned closingdate1-mei-2009
- Target number of participants50
- InterventionsThe number of circulating endothelial cells, endothelial marker proteins and accumulation of AGEs (estimated by measuring skin autofluorescence with an AGE-reader) will be determined before, during and after chemotherapy. Cardiovascular status (intima-media thickness of the carotid artery, baroreflex sensitivity and 24-hour ambulatory blood pressure measurement) will be evaluated before start of chemotherapy, within 4 weeks after completion of chemotherapy and 1 year after start of chemotherapy.
- Primary outcomeThe early effects of cisplatin based chemotherapy on the number of circulating endothelial (progenitor) cells and the accumulation of AGEs, and their correlation with cardiovascular damage.
- Secondary outcome1. Evaluation of which treatment and patient related factors (for example chemotherapy dose and presence of cardiovascular risk factors) predispose to cardiovascular damage during and after cisplatin based chemotherapy; 2. Determination of circulating apoptosis markers during and after cisplatin based chemotherapy and their relation to tumor response and cardiovascular damage.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES E.C. Haas de
- CONTACT for SCIENTIFIC QUERIESMD. PhD. J.A. Gietema
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Internal Medicine: Division of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryLong-term survivors of testicular cancer cured with cisplatin based chemotherapy are at increased risk of developing cardiovascular disease. One of the potential mechanisms behind the development of cardiovascular disease is endothelial damage. We hypothesise that a chemotherapy induced reduction in circulating endothelial (progenitor) cells and accumulation of advanced glycation end products (AGEs) due to chemotherapy induced oxidative stress, might contribute to cardiovascular damage. In this prospective non-randomised cohort study in 50 patients with disseminated testicular cancer, circulating endothelial cells and accumulation of AGEs (reflected by skin autofluorescence) will be measured before, during and after (up to 1 year) cisplatin based chemotherapy and related to cardiovascular changes, as assessed by cardiovascular funcyion tests. With this study we hope to get insight into the underlying mechanisms of chemotherapy induced cardiovascular damage and to find feasible surrogate markers for this damage, which may contribute to the early detection of cardiovascular toxicity and to the design of intervention strategies.
- Main changes (audit trail)
- RECORD19-mei-2006 - 20-jul-2006


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