alle kinderkanker childhood cancer pediatric oncology
Conditions
Interventions
None listed
Sponsors
Prinses Máxima Centrum voor Kinderoncologie
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: Informed consent will only be asked of patients in cohort B, C and the counseled subset of cohort 0. - Female gender - Age 0-18 years - Confirmed new diagnosis of pediatric cancer or relapse since start of the study or counseled since the opening of the Princess Máxima Center in 2015. Additional inclusion criteria for cohort A - none Additional inclusion criteria for cohort B - Written informed consent - Intermediate to high risk of infertility defined as >50% risk of infertility or Premature Ovarian Insufficiency (POI) and received counseling by a fertility specialist. - Low risk of infertility (
Exclusion criteria
Exclusion criteria: Additionally a subject who meets any of the following criteria will be excluded from participation in the subgroup C opting for OTC - Parents and/or patients > 12 years unable to understand the treatment- and/or study information even in the presence of an interpreter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort A Primary endpoint: - Percentage of girls diagnosed with cancer who received fertility information (verbal and written information), by documenting: - Percentage of girls diagnosed with cancer who received fertility information (verbal and written information) Cohort B Primary endpoint - Percentage of girls to whom fertility counselling is offered prior to start gonadotoxic treatment and who received additional fertility counseling by fertility expert. Cohort C Primary endpoint: Evaluation of OTC in a national cohort - Rate of complications within one month of the surgery and relatable to the surgery with CTCAE score of 3 or above, including: - bleeding requiring blood transfusion or other treatment, - bowel perforations requiring additional surgery or inter-operative repair, - infection requiring antibiotics within one week of the surgery, - other complications relatable to the surgery with CTCAE score of 3 or above. - Percentage longer hospitalisation (in days) due to complications of the OTC, - Percentage of laparoscopic procedures vs. laparotomic procedures, - Delay in initiation of oncological treatment (days)(median range), - Determinants of delay in initiation of oncological treatment (>48h), - Success rate of combination of OTC with planned anesthesia/surgery (percentage of procedures). Cohort 0 Primary endpoint: - Percentage of girls diagnosed with cancer who received fertility information (verbal and written information). | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort A Secondary endpoints: - To determine characteristics of patients receiving fertility information, by documenting: - Time interval between cancer diagnosis and fertility information (days) - Percentage of girls in which fertility information is offered within 24-48 hours from diagnosis/treatment conversation (working days) - Percentage of girls in which information is offered prior to start gonadotoxic treatment - Percentage of girls with respectively low risk, intermediate risk and high risk of developing primary ovarian insufficiency (POI): premature menopause or acute ovarian failure (AOF) after cancer treatment - to evaluate the impact of receiving information regarding fertility at the time of cancer diagnosis using standard of care questions in KLIK at the end of treatment and qualitatively analyzing these and documenting the percentage of girls > 12 year and parents who perceive to be well informed on their risk of infertility, - to determine the influence of diagnosis and treatment on the remaining gonadal reserve, reflected by anti-müllerian hormone (AMH), follicle-stimulating hormone (FSH), estradiol and luteinizing hormone (LH) levels and menstrual cycles (secondary amenorrhea) and longitudinal hormone level development over time, at diagnosis and after cessation of treatment. Cohort B Secondary endpoints: - To determine characteristics of patients receiving fertility counseling, - To evaluate the motivation for choosing for or against OTC 1-2 months (range 1-6 months) after counseling and identification of the barriers to referral for counseling and for OTC, and at what stage of the referral pathway such barriers occurred - To evaluate the impact of receiving fertility counseling fertility at the time of cancer diagnosis 1-2 months (range 1-6 months) after counseling and qualitatively analyzing these and documenting the percentage of girls > 12 year and parents who perceive to be well informed on their risk of infer | — |
Countries
Netherlands
Outcome results
None listed