To investigate the state of the endothelial glycocalyx in cancer patients and determine the effect of chemotherapy on this layer.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of the glycocalyx in cancer patients and comparison to healthy
controls by
- Orthogonal Polarisation Spectroscopy (OPS)
- Blood/urine parameters
Secondary outcome
The influence of chemotherapy on the primary parameters.
Correlation of the glycocalyx state to the activation of the coagulation and
clinical data after 3 months of follow-up.
Background summary
Functions of the endothelial glycocalyx are the preservation of the endothelial
barrier and to prevent adhesion of cells to the endothelial wall. In cancer,
elevated levels of heparanase and hyaluronidase are described, which are
enzymes extensively described in local tumour invasiveness. However, these
enzymes are also known for their glycocalyx degrading effects. The glycocalyx
has not been described in cancer patients yet. A damaged glycocalyx might allow
adhesion of cancer cells to the blood vessel wall and these cells can more
easily cross the vessel wall. This way, metastasis would be promoted. Also, the
hypercoagulant state in cancer might be in part due to a perturbation of the
glycocalyx. Chemotherapy is known to induce endothelial damage, probably also
to the glycocalyx, which may explain the hypercoagulant state caused by
chemotherapy. Alternatively, restoration of the glycocalyx may be one of the
anti-tumour effects of chemotherapy, possibly via inhibition of the production
of the glycocalyx degrading enzymes.
Study objective
To investigate the state of the endothelial glycocalyx in cancer patients and
determine the effect of chemotherapy on this layer.
Study design
Observational case-control study
Study burden and risks
The patients will visit the hospital on three occasions, of which two in a semi
fasting state (3 hours no food-intake). On the first occasion, screening is
done and informed consent is taken. During the first research visit, before
chemotherapeutic therapy has been initiated, the patients will be asked to fill
out a questionnaire and they will undergo OPS measurement (non-invasive imaging
of the sublingual microcirculation) and venapuncture (blood withdrawal 30 ml).
Also, they will be asked to hand over one portion of urine.
During the second visit, after the start of chemotherapy, the same procedure
will take place.
After three months of follow-up, information about the progression of the
disease will be obtained (no extra visit needed).
Visits will be planned simultaneously with visits for regular patient care.
Also, blood withdrawings will be planned simultaneously with blood withdrawings
for regular patient care as much as possible.
Meibergdreef 9
1100 DD
Nederland
Meibergdreef 9
1100 DD
Nederland
Listed location countries
Age
Inclusion criteria
Men and postmenopauzal women
Aged over 18 years
Informed consent
Metastasized gastric or oesophageal or colon cancer, not yet started with chemotherapy
Multiple myeloma;Healthy volunteers: healthy men or post-menopauzal women, aged over 18, informed consent
Exclusion criteria
Diabetes mellitus
Cardiovascular disease
Medication used for the above mentioned diseases
Pre-menopauzal women
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL26451.018.08 |