To respectively evaluate the fertility parameters before and after treatment for pediatric HL in the Netherlands according to the COG protocols for low risk, intermediate risk and high risk, to test the hypothesis that these protocols will not harm…
ID
Source
Brief title
Condition
- Lymphomas Hodgkin's disease
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study will give insight inthe direct and late effects of the used
chemotherapy in pediatrics patients with HL using the most novel fertility
markers. If these chemotherapeutic agents do not show gonadal damage, it will
support future studies with these agents. If certain regimens indicate direct
or late gonadal toxicity, this will urge early counceling in this cohort.
Secondary outcome
not applicable
Background summary
In a retrospective study, in a cohort of 86 adults treated for pediatric HL
with chemotherapy only in Amsterdam and Rotterdam, after a median follow-up of
25 years fertility parameters were investigated. The results showed in this
long term follow-up cohort, that Inhibine B was the best predictor for
infertility in men. AMH was found to be decreased in women who received MOPP
even in patients with normal FSH and in contrast to women who received EBVD
only.
Study objective
To respectively evaluate the fertility parameters before and after treatment
for pediatric HL in the Netherlands according to the COG protocols for low
risk, intermediate risk and high risk, to test the hypothesis that these
protocols will not harm gonadal function.
Study design
Pediatric patients treated in the Netherlands according to a COG Hodgkin
protocol, boys 8 yrs and > 8 yrs at diagnosis, girls 9 yrs and > 9 yrs at
diagnosis.
At 3 time points: 1. before start treatment, 2. after treatment, 3. three years
after treatment (or if pts have not reached the age of 18 at the age of 18 yrs)
At time point 3 also emen analysis.
Study burden and risks
Bloodsampling can be painfull with possible bruising, infection or bleeding.
However, bloodsampling can be performed during routine blood sampling.
Leyweg 299
2545CJ Den Haag
Nederland
Leyweg 299
2545CJ Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
Pediatric patients treated in the Netherlands according to the COG Hodgkin Disease protocols, boys > 8 years, girls > 9 years
Exclusion criteria
Pediatric patients not treated on a COG Hodgkins'Disease protocol, boys < 8 yrs, girls < 9 yrs
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 | NL12889.042.06 |