Markers for Acute Chemotherapy-Induced Cardiovascular Changes
| ISRCTN | ISRCTN54551960 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54551960 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/07/2006
- Registration date
- 19/07/2006
- Last edited
- 19/07/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr E.C. Haas de
Scientific
Scientific
Medische Oncologie
University Medical Center Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
| Phone | +31 (0)50 3612821 |
|---|---|
| e.c.de.haas@int.umcg.nl |
Study information
| Study design | An observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | MACC1 |
| Study objectives | 1. 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 |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Testicular cancer |
| Intervention | The 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 four weeks after completion of chemotherapy and one year after start of chemotherapy. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cisplatin |
| Primary outcome measure | The 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 outcome measures | 1. Evaluation of which treatment and patient-related factors (for example chemotherapy dose and presence of cardiovascular risk factors) predispose patients 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 |
| Overall study start date | 16/05/2006 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Male |
| Target number of participants | 50 |
| Key inclusion criteria | 1. 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 |
| Key exclusion criteria | 1. Medical history of cardiovascular disease 2. Known renal disease or estimated glomerular filtration rate (GFR) <60 ml/min (using Cockcroft-Gault formula) |
| Date of first enrolment | 16/05/2006 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Medische Oncologie
Groningen
9713 GZ
Netherlands
9713 GZ
Netherlands
Sponsor information
University Medical Center Groningen (UMCG), Department of Internal Medicine: Division of Medical Oncology (The Netherlands)
University/education
University/education
P.O. Box 30001
Groningen
9700 RB
Netherlands
"ROR" |
https://ror.org/03cv38k47 |
|---|
Funders
Funder type
University/education
University Medical Center Groningen (UMCG)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
