This prospective evaluation of the dynamics of thyroid hormones during cancer treatment in children is designed to determine the prevalence of thyroid hormone deficits at diagnosis, during and directly after treatment and to study changes in thyroid…
ID
Source
Brief title
Condition
- Thyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Prevalence of hypothyroidism (% of study cohort) defined as TSH > reference
interval (5.0 mU/L) at the four time points
2. Severity of hypothyroidism at the 4 time points defined as:
- Mild (TSH> 5, FT4 within the reference ranges)
- Moderate (TSH > 10 mU/L, FT4 within reference ranges)
- Severe (TSH above 10 mU/L, FT4 < reference ranges)
Secondary outcome
1. Prevalence of non-thyroidal illness (% of study cohort) defined as FT4 <
reference range in combination with elevated rT3 level) at the four time points.
2. Severity of non thyroidal illness at the four time points defined as:
- Mild (FT4 9-10 pmol/L)
- Moderate (FT4 7-9 pmol/L)
- Severe (FT4 <7 pmol/L)
3. The individual changes (delta Δ) of FT4 in pmol/l, TSH in mU/L and rT3 in
pmol/l at the 4 time points will be explored.
4. The prevalence of auto-immune disease will be determined by the number of
patients with elevated anti-TPO concentrations (positive defined as: >35 U/mL
(ELiA)).
Background summary
Endocrine dysfunction is increasingly reported as side effect of upcoming new
cancer drugs. Chemotherapy may influence thyroid hormone concentrations due to
direct thyroid gland damage (disruptive) or as a consequence of an adaptation
mechanism of the body to illness (adaptive). Low thyroid hormones in children
may cause fatigue, growth or mental retardation, constipation, or have
cardiovascular consequences. There is however, hardly any information on the
dynamics of thyroid hormones during chemotherapy in children. For these
reasons, there is need for knowledge upon the prevalence and magnitude of
thyroid disturbances in this population.
Study objective
This prospective evaluation of the dynamics of thyroid hormones during cancer
treatment in children is designed to determine the prevalence of thyroid
hormone deficits at diagnosis, during and directly after treatment and to study
changes in thyroid hormone metabolism during cancer treatment in children.
Study design
In this prospective observational study, during a 2-year period, children with
a new diagnosis of leukemia, sarcoma, lymphoma or a brain tumor and all
children undergoing a stem cell transplantation will be included. Thyroid
function will be monitored at 4 time points. Prevalence, severity and
individual changes of thyroid function will be determined.
Study burden and risks
The burden or risk for the patients is considered as minimal as the blood will
be drawn at time points that the children would have had blood drawn also for
other reasons. Furthermore for clinical practice already every 3 months
questionnaires are being administered via a website (www.hetKLIKt.nu), which is
implemented in a web-based method in the Princess Máxima Centre with electronic
patient reported outcomes that give a clear overview of the quality of life of
pediatric oncology patients and their parents. This portal can also be used to
administer questionnaires for research online. Patients included in this study
will not visit the Princess Maxima Center more often during this study because
of study purposes.
Heidelberglaan 25
Utrecht 3584 CS
NL
Heidelberglaan 25
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
Children (< 21 years) who are diagnosed with leukemia, sarcoma, lymphoma or
brain tumor and all children undergoing a stem cell transplantation in the
period 2019-2021 in the Princess Máxima Center will be evaluated for inclusion.
Exclusion criteria
- Patients known with previous thyroid disease and receiving thyroid hormone
substitution therapy
- Patients diagnosed with Down Syndrome or Cowden syndrome
- Patients known with or suspicious for MEN I or II syndrome
- History or neck radiation or MIBG treatment
- Diagnosis of pituitary tumor, craniopharyngioma
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 | NL68860.041.19 |