the investigation and evaluation of certain serummarkers for inflammation and tumoractivity during the followup of colorectal neoplasms, and the applicability of these markers during the followup of these patients or the evaluation of the effect of…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Health condition
chemo- en radiotherapeutische voorbehandelingseffecten op maagdarm neoplasmata
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Parameters which will be evaluated are the following:
- CRP (C-Reactive Protein)
- Leucocytes
- CEA (Carcino Embrionic Antigen)
- flowcytometric measurement of CEA in activated macrophages
- flowcytometric measurement of M30 in activated macrophages
- flowcytometric measurement of Cytokeratine 18 in activated macrophages
- tumor regression by chemoradiation-therapy
Secondary outcome
not available
Background summary
Patients who recently underwent colorectal surgery for colorectal neoplasms
will be followed during 6-9 months to evaluate recurrence. Recurrence of
colorectal carcinoma occurs frequently, especially in the first one and a half
years. It is quite hard to predict a recurrence. The carcino embrionic
antigen(CEA) is a marker that is currently used to predict a recurrence. beside
the CEA-measurement, a CT-scan is performed once a year. Sadly enough this
method does not predict all recurrences. reasons why are, intervals that are
too long between blood-sampling, errors in the samples, and the compliance of
the patients.
If CEA is increased a CT-scan is made and with a proof of recurrence, the
patient will be treated. CEA is also increasing on several other occasions and
in those occasions a CT-scan is performed which were not neccesary. CEA is not
thrustworthy as a parameter and can also be increased in other circumstances in
the human body. To investigate if other parameters can be able to indicate a
recurrence, a couple of thouroughly selected parameters will be investigated
together with the CEA in the serum of these patients. Also new diagnostic
methods in patients suffering from colorectal carcinoma will be investigated,
for example flowcytometrical analysis.
patients suffering from rectal carcinoma who will be pre-treated with
chemoradiaton therapy will be checked for tumor downsizing and lymphnode
pathology pre en post chemoradiation therapy
Study objective
the investigation and evaluation of certain serummarkers for inflammation and
tumoractivity during the followup of colorectal neoplasms, and the
applicability of these markers during the followup of these patients or the
evaluation of the effect of pretreatment in patients suffering from rectal
carcinoma by chemoradiation therapy.
Study design
propective diagnostic research
Study burden and risks
except for the standard-procedure:
- blood-sampling every 1 to 2 months 8 tubes a 3 ml (18 ml) for 2 years
risc's:
- bleeding from the site of blood-sampling.
- infection of the site of blood-sampling
Henry Dunantstraat
postbus 4446, 6401 CX Heerlen
NL
Henry Dunantstraat
postbus 4446, 6401 CX Heerlen
NL
Listed location countries
Age
Inclusion criteria
patient before pre-treatment of or who recently underwent (pre-treatment for) colorectal surgery for colorectal neoplasmata
Exclusion criteria
no exclusion criteria
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 | NL14215.096.06 |