Produce a reproducible method for enumeration of CECs and CEPs in peripheral blood in order to further study the usefulness of CECs and CEPs as a biomarker in LDM therapy.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A reproducible method for enumeration of CECs and CEPs in peripheral blood
using FACS
Secondary outcome
Gain further insight in the origin of CECs and CEPs.
Background summary
CEC and CEPs play een important roll in angiogenisis both in health tissiue and
in tumor tissue. In patients with cancer these cells are up regulated.
Higher numbers of CEC/CEPs negatively correlate to survival of patients after
chirugery and also for chemotherapy.
In traditionally administered chemotherapy a burst release of CECs and CEPs is
seen shortly after therapy. This burst release is related to a pro-angiogenic
state in which the vasculature of the tumor is restored resulting in tumor
growth and therefore limiting efficacy of therapy.
In metronomic therapy traditional chemotherapeutic agents are given in very low
doses. These low doses are toxic to CEC and CEPs and therefore inhibit tumor
growth, since the lack the ability to restore the tumor vasculature will result
in ischemia and will thereby halt tumor growth.
Because of the reasons mentioned above we see additional value for CEC/CEPs as
a diagnostic marker. With the development of this assay we hope to be able to
better predict efficacy of metronomic therapy in cancer patients.
Study objective
Produce a reproducible method for enumeration of CECs and CEPs in peripheral
blood in order to further study the usefulness of CECs and CEPs as a biomarker
in LDM therapy.
Study design
Both healthy individuals and cancer patients will be asked to donate blood for
the further development and validation of the CEC/CEP FACS assay.
Only blood collection will be performed. Inclusion will be performed only if
samples of patients/controls are needed.
Study burden and risks
The burden for the patients will be limited, extra blood will be collected
during a regular visit. Up to 24ml of blood will be drawn per time point.
Patients will be asked to donate blood up to 5 times.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
bInclusion criteria cancer patients:
1. Patients with histological or cytological proof of metastatic cancer.
2. Age * 18 years
3. Able and willing to give written informed consent
4. Able and willing to undergo blood sampling ;Inclusion criteria healthy volunteers:
1. Age * 18 years
2. Able and willing to give written informed consent
3. Able and willing to undergo blood sampling
Exclusion criteria
Exclusion criteria cancer patients:
1. Patients with known alcoholism, drug addiction, psychotic disorders in the history and/or other reasons, for which they are not amenable for adequate follow up.
2. Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients ;Exclusion criteria healthy volunteers:
1. Patients with known alcoholism, drug addiction, psychotic disorders in the history and/or other reasons, for which they are not amenable for adequate follow up.
2. Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients
3. Prior history of malignancy, renal disease, cardiovascular disease.
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 | NL46654.031.14 |