1. Test if serum levels of S-100B are elevated in serum that contains frozen adipocytes2. Test if serum levels of S-100B are elevated in serum that was collected with a troublesome venipuncture 3. Test if serum levels of S-100B are lower in the…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
S-100B will be measured in µg/L. The median level of S-100B is 0.10 µg/L, with
a RCV of 41% a value higher than 0.14 *g/l will be a significantly higher value
of S-100B.
Secondary outcome
Not applicable
Background summary
S-100B is a biomarker that reflects melanoma tumour load and is currently more
frequently used in stage IV melanoma patients to assess the progression of
melanoma disease as well as treatment effectiveness.[1,2]
S-100B as a tumor marker is currently more frequently used in the treatment of
melanoma patients.[1-3] Moreover, more recently its prognostic significance in
Stage III disease was described.3 S-100B is a 21 kilo Dalton protein that is
found in glial- and Schwann cells.3 Its intracellular concentration is found to
be high in melanoma cells and increased serum levels are seen in patients with
substantial melanoma tumor load.4 However, elevated S-100B levels were also
found in patients with trauma capitis, weight reducting or starving, extreme
physical exercise and stress.5,6 In starvation, S-100B will rise because of
reduction of the adipocytes that contain S-100B.7 Several studies have shown
that S-100B can be released by adipocytes.5,7-15
In case of a troublesome venipuncture, the needle will damage adipocytes of the
sub cutis before reaching the vein. Therefore serum S-100B levels might be
higher in samples taken with a troublesome venipuncture compared with samples
that were taken with an unhampered venipuncture where no adipocytes were
destroyed. However, serum S-100B determination in a second tube is should not
be influenced by the difficulty of the venipuncture, as collection of the first
tube of blood will clear the needle from adipocytes.
If troublesome venipunctures lead to falsely elevated S-100B levels, S-100B
analysis in only the second tube could increase sensitivity of this melanoma
tumour marker. An increase in sensitivity of S-100B levels could improve the
clinical impact of this biomarker and could even narrow its reference
interval. This improved sensitivity would enable the use of this biomarker in
earlier stages of melanoma.The aim of the present study is to investigate the
effect of a troublesome venipuncture on measured serum level of S-100B.
Study objective
1. Test if serum levels of S-100B are elevated in serum that contains frozen
adipocytes
2. Test if serum levels of S-100B are elevated in serum that was collected with
a troublesome venipuncture
3. Test if serum levels of S-100B are lower in the second tube, also collected
with the troublesome puncture
Study design
In our study we will analyze the 3 objectives in two steps.
1) S-100B is first analyzed in serum of two healthy individuals. Serum will be
collected will normal venipuncture and will afterwards be contaminated with
adipocytes. Adipocytes are collected by puncturing subcutaneous fat of the
abdominal wall of the participants. S-100B is analyzed in this tube and
compared with normal values for S-100B. If S-100B is indeed higher than normal,
the study will be continued with step 2.
2) Troublesome venipuncture is performed in 20 healthy participants by
injecting the needle at cubital fossa of the upper forearm first in at least
1cm of sub cutis before injecting it in the vein. Two tubes of serum are
collected and analyzed for S-100B. The difference in serum levels of S-100B of
the two tubes will be analyzed to determine objectives 2 and 3.
Intervention
Venipuncture in healthy participants the needle will be injected at the cubital
fossa of the upper forearm first in at least 1-2cm of sub cutis before
injecting it in the vein.
Study burden and risks
Venipuncture can lead to several complications. Occasionally, a participant may
bleed longer than normal after a vein puncture. This is more common in taking
anticoagulants, aspirin and certain other drugs are also at increased risk of
this complication, which is why these participants will be excluded. Some
participants may develop a hematoma under the skin. Moreover the procedure
could be painful and participants could faint. These complications are rather
harmless and normally no treatment is necessary. Of course we will try to avoid
these complications by putting pressure on the venipuncture wound for a minute
after the venipuncture.
Participants will be informed about their S-100B level if this is elevated.
Although S-100B levels are meaningless in people without a melanoma, we think
we ought to tell these participants as they could have a melanoma. Participants
will be assisted in follow-up options in case of an elevated level of S-100B.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Healthy participants with an age between 18 and 65 years old
Exclusion criteria
A major disease of the nervous system or cancer, use of medication, recent heavy weight loss, major stress, recent extreme physical activity, pregnancy, use of soft/hard drugs or smoking. These criteria will be determined using a questionnaire.
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 | NL42601.042.12 |