Pediatric oncology, infertility
Conditions
Interventions
None
Sponsors
Princess Maxima Center
Eligibility
Inclusion criteria
Inclusion criteria: - Written informed consent - Female gender - Age 0-18 years - Confirmed new diagnosis of pediatric cancer or relapse since start of the study Additional inclusion criteria for cohort A - none Additional inclusion criteria for cohort B - Intermediate to high risk of infertility defined as >50% risk of infertility or Premature Ovarian Insufficiency (POI). - Low risk of infertility (50%) of POI and eligible for OTC according to the amended Edinburgh criteria. - A realistic chance of survival for 5 years and undergoing curative treatment, - Opted for OTC - Written informed consent for OTC Additional inclusion criteria for cohort 0 - Patients newly diagnosed with pediatric cancer or relapse between May 2018 and start of the study or have undergone OTC between May 2018 and the start of the study.
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 - Oncological contra-indications to delay treatment to allow OCT - POI - Contra-indication for laparoscopy or laparotomy - 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: Measuring the number of patients receiving fertility information with the intention to inform all girls newly diagnosed with cancer and their families, by documenting: - Percentage of girls diagnosed with cancer who received fertility information (verbal and written information) Cohort B Primary endpoint: Measuring the number of patients receiving fertility counseling by documenting: - 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 such as bleeding requiring blood transfusion or other treatment, bowel perforations requiring additional surgery or inter-operative repair, infection requiring antibiotics within four weeks of the surgery and relatable to the surgery using CTCAE criteria. - 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 The primary endpoint of cohort 0 is to evaluate the number of patients who received fertility information in the first year of the Princess Máxima Center through a retrospective chart review by documenting: - 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 a questionnaire 1 year after diagnosis or 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), by documenting: - Percentage of girls with secondary amenorrhea, in girls aged over 11 years old and 1 year after cessation of therapy - Longitudinal hormone level development over time, at diagnosis, after cessation of treatment and 1 year after discontinuation of therapy Cohort B Secondary endpoints: To determine characteristics of patients receiving fertility counseling by documenting - Time interval between first counselling and record of decision regarding OTC (days) - Percentage of girls in which counseling is offered within 24-48 hours from diagnosis/treatment conversation (working days) - Percentage of patients with a written report of the counseling on a standardized but personalized form within 4 days of the counseling. To evaluate the motivation for choosing | — |
Contacts
Public ContactMadeleine van der Perk
Prinses Máxima Centrum voor kinderoncologie
Outcome results
None listed