To determine the feasiblity of the detection of disseminated tumor cells in bone marrow with RT-qPCR
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence of disseminated tumor cells in bone marrow, which means an
elevated signal of CK20 and CEA in the RT-qPCR.
Secondary outcome
none
Background summary
Colon cancer is one of the most common cancer in the Netherlands. The most
important predictor of survival is the presence of lymph node or distant
metastasis.
Still, in 30-45% of the patients with curatively resected colon cancer with no
lymph node involvement, local regional recurrence or distant metastasis will
occur.
A plausible explanation could be the dissemination of tumor cells via blood or
lymphatic system.
A method for detection of disseminated tumor cells is RT-qPCR. With RT-qPCR it
is possible to detect specific genetic markers on tumor cells. In colon
carcinoma, the expression of the genetic markers CK-20 and CEA are often
elevated.
Since metastasis occur mainly via blood stream and the lymphatic system, tumor
cells can be found in blood and bone marrow.
Study objective
To determine the feasiblity of the detection of disseminated tumor cells in
bone marrow with RT-qPCR
Study design
During surgery, two bone marrow needle aspiration are performed, when the
patient is under full anesthesia. The puncture site is the spina illiaca
anetrior superior. The first punction will be performed during surgey, when the
tumor has not yet been resected. The second puncture will be performed as soon
as the specimen is out of the patient.
The aspirated bone marrow will be conserved in a special medium en be brought
to the laboratory. Here, the RT-qPCR will be performed and the aspirated bone
marrow will be analysed for the presence of tumor cells.
Study burden and risks
The bone marrow aspiration will be performed during surgery by the operating
surgeon under a sterile environment. The actual surgery will not take extra
time. Also, the risk of infection is minimalised by performing the procedure
under sterile conditions.
After an needel aspiration, there's a risk of hemorrhage. This risk is no
greater than after an arterial punction. After aspirating bone marrow, the
aspiration site will be compressed and a pressure bandag will be applied.
Pettelaarseweg 629
5216 BN 's Hertogenbosch
Nederland
Pettelaarseweg 629
5216 BN 's Hertogenbosch
Nederland
Listed location countries
Age
Inclusion criteria
proven colon carcinoma
no pre-operative suspicion of distant metastasis
older than 18 years
written informed consent given
Exclusion criteria
distant metastasis
irresectable tumors
hemophilia
disseminated intravascular coagulopathy
no informed consent given
younger than 18 years
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 | NL18942.028.07 |