Anti-Müllerian hormone is a marker of gonadotoxicity in pre- and postpubertal girls treated for cancer: a prospective study.
Mark F H Brougham, Patricia M Crofton, Emma J Johnson...
https://pubmed.ncbi.nlm.nih.gov/22472563Actively Recruiting
Led by Erasme University Hospital · Updated on 2020-05-04
275
Participants Needed
10
Research Sites
782 weeks
Total Duration
E
Erasme University Hospital
Lead Sponsor
Q
Queen Fabiola Children's University Hospital
Collaborating Sponsor
Researchers are studying how Antimüllerian 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, moderate/low, 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; moderate/low 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
AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at inclusion
Duration - At inclusion
Participants undergo baseline evaluations including hormonal dosages and pubertal status assessment to determine ovarian reserve and puberty stage.
1 baseline visit (in-person)
Duration - Up to 15 years until participants reach 18 years old
Participants are monitored over time with repeated hormonal assessments, puberty evaluations, and bone age X-rays to track ovarian reserve and pubertal development.
Annual visits for the first 3 years, then every 2 years until age 18
Total: 10 locations
1
Centre Hospitalier Chrétien (CHC)- Clinique de l'espérance
Montegnée, Liège, Belgium, 4420
Actively Recruiting
2
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium, 2650
Actively Recruiting
3
Hôpital Universitaire Reine Fabiola (HUDERF)
Brussels, Belgium, 1020
Actively Recruiting
4
Universitair Ziekenhuis Brussels
Brussels, Belgium, 1090
Actively Recruiting
5
UZ-Gent
Ghent, Belgium
Not Yet Recruiting
6
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
7
Centre Hospitalier Régional (CHR)-Citadelle
Liège, Belgium, 4000
Actively Recruiting
8
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
9
CHRU Lille-Hôpital Jeanne de Flandre
Lille, France, 59037
Actively Recruiting
10
Hôpital Robert Debré
Paris, France
Not Yet Recruiting
I
Isabelle Demeestere, PhD
J
Julie Dechene
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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