Actively Recruiting
Antimllerian Hormone as a Predictor of Future Infertility Risk in PrepubertalPubertal Cancer Patients
Led by Erasme University Hospital · Updated on 2020-05-04
275
Participants Needed
10
Research Sites
782 weeks
Total Duration
On this page
Sponsors
E
Erasme University Hospital
Lead Sponsor
Q
Queen Fabiola Children's University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how Antimllerian Hormone AMH levels can predict the risk of future infertility in girls aged 3 to 14 who are undergoing cancer treatment or treatment for benign diseases. The goal is to identify young patients who may have a reduced ovarian reserve after treatment and could benefit from special follow-up or fertility preservation. The study includes children at high, moderatelow, or no risk of ovarian damage from chemotherapy or pelvic irradiation. The study observes AMH and other hormone levels before and after treatment, with no interventions applied. Participants are grouped by their risk level high risk patients receiving conditioning therapy or pelvic irradiation moderatelow risk patients treated with chemotherapy regimens for various cancers and a control group with no risk, consisting of patients with benign diseases or cancers not requiring gonadotoxic treatment. Assessments occur at diagnosis, treatment end, and during follow-up visits scheduled yearly for three years, then every two years until age 18. Participants will have their ovarian reserve evaluated through hormone tests including AMH, FSH, estradiol, testosterone, and LH, alongside menstrual cycle tracking and pubertal development assessed annually using Tanner staging and bone age X-rays. The primary outcome is the AMH marker measured regularly up to 18 years old. Secondary outcomes include premature ovarian failure and ovarian reserve changes. The study also monitors oncological outcomes as per standard care, with a total follow-up duration extending to 18 years old.
CONDITIONS
Brief Title
AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 3 to 14 years old
- Patients belonging to one of three risk groups: high risk (conditioning therapy for bone marrow transplantation or pelvic irradiation), moderate/low risk (chemotherapy for specified cancers), or no risk (no chemotherapy or gonadotoxic treatment)
- Diagnosed with cancer or benign diseases requiring chemotherapy and/or pelvic irradiation
- Newly diagnosed patients at the time of enrollment
You will not qualify if you...
- History of central nervous system irradiation or cerebral tumor
- Current or previous ovarian disease or ovarian surgery
- Family history of premature ovarian failure not caused by treatment or surgery
- Severe chronic diseases affecting growth or puberty (including malnutrition, anorexia, genetic/congenital disorders like Turner or Kallman syndromes, uncontrolled diabetes, Cushing Syndrome, autoimmune diseases, cystic fibrosis, severe renal dysfunction)
- Genetic or congenital disorders causing mental retardation
Research Team
I
Isabelle Demeestere, PhD
J
Julie Dechene
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