Condition category
Cancer
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
19/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E.C. Haas de

ORCID ID

Contact details

Medische Oncologie
University Medical Center Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
+31 (0)50 3612821
e.c.de.haas@int.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

MACC1

Study hypothesis

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

Not provided at time of registration

Study design

An observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Cisplatin

Primary outcome measures

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 trial start date

16/05/2006

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

50

Participant 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)

Recruitment start date

16/05/2006

Recruitment end date

01/05/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Medische Oncologie
Groningen
9713 GZ
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG), Department of Internal Medicine: Division of Medical Oncology (The Netherlands)

Sponsor details

P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Medical Center Groningen (UMCG)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes