1. To assess the prevalence of severe male subfertility in adult male survivors of childhood cancer in relation to type and intensity of treatment and age at time of treatment. 2. To assess the diagnostic value of inhibin B and AMH for the…
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
prevalence of subfertility diagnostic value of inhibin B and AMH reproductive
history and health of offspring
Secondary outcome
not applicable
Background summary
Advances in diagnosis and treatment of childhood cancer over the last decades
have dramatically increased long-term survival. As a result, the numbers of
childhood cancer survivors (CCS) are growing and it has become increasingly
clear that the former disease and its treatment can significantly impair
long-term health. The need for long-term follow-up is uniformly recognized.
Research focusing on identification and characterization of high-risk
populations is an essential foundation on which to build evidence-based
recommendations for long-term follow-up. Furthermore, research focusing on more
accurate screening tests and effective interventions is needed to reduce excess
morbidity and mortality in CCS. this research proposal on fertility in male
childhood cancer survivors is part of the large national study and focuses on
the effect of previous anti cancer treatment on fertility when the patient has
reached adulthood.
Study objective
1. To assess the prevalence of severe male subfertility in adult male survivors
of childhood cancer in relation to type and intensity of treatment and age at
time of treatment. 2. To assess the diagnostic value of inhibin B and AMH for
the prediction of male subfertility in adult survivors of childhood cancer. 3.
To assess the reproductive history (method of conception, number of life
births, pregnancy outcomes) in adult survivors of childhood cancer in relation
to type and intensity of treatment and age at time of treatment. 4. To assess
the health of offspring from male childhood cancer survivors
Study design
The study involves a cross-sectional study of a retrospective nationwide cohort
of 5-year survivors of childhood cancer (diagnosed 1960-2001) in the
Netherlands. 2700 survivors will be included.
Study burden and risks
The survivors will be invited for the Q2008 SKION LATER study close to a visit
to the LATER out patient clinic. the visit for the research questions will be
linked to visits to the clinic for regular patient care. for the study, extra
blood (15 minutes) will be drawn when a venapuncture is done for patient care.
extra questionaire has to be filled in (5-15 minutes) and semenanalysis will be
done (10 - 20 minutes). participation will not benefit the survivors, except
when they wish to have information on their fertility. it is known from earlier
research that a large proportion of the survivors has such a wish. the group of
survivors benefits from the study since they can be informed on risks of
infertility and better tools will be available to measure infertility. future
pediatric cancer patients benefits since with the results of the study new
treatment protocols can be designed with less toxicity.
Heidelberglaan 25
Utrecht 3584CS
NL
Heidelberglaan 25
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
adult (> 18 yrs of age) male patients who were treated for childhood cancer
(before age 18) in one of the Pediatric Oncology Centers between 1960 and 2001
and who survived for at least 5 years after diagnosis will be included in the
SKION LATER study. Participating centres are located in Amsterdam (VU
University Medical Center (VUMC)), Groningen (Children's Cancer Center/
University Medical Center Groningen (UMCG)), Rotterdam (Rotterdam Erasmus
MC-Sophia (REMC-S), Nijmegen (University Medical Center Nijmegen (UMCN)),
Leiden (Leiden University Medical Center (LUMC) and Utrecht (Princess Máxima
Center for Pediatric Oncology (PMC)).
Exclusion criteria
diagnosis of childhood cancer with survival less than 5 years, age at diagnosis
>17 years or diagnosis while residing in foreign country; females
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 | NL34909.018.10 |