The aim of this project is a prospective study of blood samples of HL patients to determine the value sensitivity and specificity of increase TARC an MDC serum levels for the early detection of a relapse.
ID
Source
Brief title
Condition
- Lymphomas Hodgkin's disease
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Including children with Morbus Hodgkin in the Netherlands in this study will
give a larger power to this study and does mean sooner sufficient patient
accrual to achieve a reliable result concerning the value of TARC monitoring to
determine the disease activity.
* In adult patients is has been proved that the TARC level after treatment
has a prognostic value. By including children with Morbus Hodgkin we'll be able
to determine if this is also the case with children.
* By collecting blood during treatment we possibly can get a good idea about
the disease activity and efficiency of the treatment.
Secondary outcome
If the sensivity of increased TARC and MDC serum levels is hight and patients
with consistent low TARC and MDC levels are free from failure, measurement of
TARC and MDC could replace expensive CT and PET scans.
Background summary
Morbus Hodgkin is a cancer of the lymphnodes with only a small amount of
tumorcells (RS cells) and a large amount of not malignant inflammatory cells.
Several studies have indicated that the interaction between the inflammatory
cells and the RS cells do play a crucial role in the pathogenesis of Morbus
Hodgkin.
Study objective
The aim of this project is a prospective study of blood samples of HL patients
to determine the value sensitivity and specificity of increase TARC an MDC
serum levels for the early detection of a relapse.
Study design
About 8 - 12 serum samples will be collected before, during and after
completion of the therapy and during follow-up. The total follow-up is 5 years
so that missing possible relapses is minimized. The total of included patients
will be the same as the total patients registered on SKION protocol COG
AHOD0031 (METC2004/019), nationally 20-25 pts/year.
Study burden and risks
Obtaining blood can be painfull with possible bruising, infection of bleeding.
However, bloodsampling can be performed during routine blood sampling.
Hanzeplein 1
30.001 9700RB GRONINGEN
Nederland
Hanzeplein 1
30.001 9700RB GRONINGEN
Nederland
Listed location countries
Age
Inclusion criteria
Children with Morbus Hodgkin (0-18 yrs) included in SKION protocol COG AHOD0031 (METc2004/019)
Exclusion criteria
Pediatric patients not treated on a COG Hodgkins'Disease protocol
Design
Recruitment
Medical products/devices used
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 | NL12825.042.06 |