Antimüllerian Hormone as a Predictor of Future Infertility Risk in Prepubertal/Pubertal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 275
- 试验地点
- 16
- 主要终点
- AMH marker
研究概览
简要总结
While most of the children spontaneously recover menstruation or experienced normal puberty after chemotherapy, their ovarian reserve may be impaired by treatment inducing future infertility. Fertility preservation is currently proposed for selected prepubertal patients with a high risk of premature ovarian failure after treatment (mostly conditioning regimen for bone marrow transplantation). For patients with low or moderate risks, counselling is very difficult and no fertility preservation procedure is usually proposed for these patients as no marker of the ovarian reserve has been validated in this young population to assess the individual risk.
The primary objective of the study is to prevent long-term treatment-related infertility by detecting the young patients who normally progressed to menarche but have a reduced ovarian reserve. These patients may benefit from particular follow-up and fertility preservation procedure.
详细描述
In this clinical trial, we will prospectively evaluate the AMH (Antimüllerian Hormone) level before and after treatment (up to 18 years old) in a large cohort of pre- and post-pubertal children treated for cancer. The children enrolled are young patients between 3 and 14 year old who are newly diagnosed with cancer or benign diseases treated by chemotherapy and/or pelvic irradiation. They belong to one of these 3 groups (modified from Wallace et al, 2005):
- High risk
- Moderate/Low risk
- No risk (control group)
Primary endpoint:
Evaluate AMH as a potential biomarker of ovarian reserve in prepubertal/pubertal girl treated by chemotherapy (classified according to the AAD(Alkylating Agent Dose) score)
Secondary endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients from 3 to 14 year old included - Belong to one of these 3 groups (modified from Wallace et al, 2005):
- •High risk : Conditioning therapy for bone marrow transplantation or pelvic irradiation
- •Moderate/Low risk : Pathologies treated with chemotherapy regimen with moderate or low risk of inducing ovarian function insufficiency: AML, osteosarcoma, Ewing sarcoma, neuroblastoma, non-Hodgkin lymphoma, Hodgkin lymphoma, soft tissue sarcoma, ALL, Wilms tumour, retinoblastoma.
- •No risk (control group) : patients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment.
排除标准
- •CNS (central nervous system) irradiation, cerebral tumour
- •Current or previous ovarian disease/surgery
- •Familial history of premature ovarian failure (no iatrogenic or surgical origins)
- •Previous known severe chronic disease potentially affecting normal growth or puberty (diseases inducing malnutrition, anorexia, genetic/congenital disorders as Turner, Kallman, BPES(Blepharophimosis, ptosis, and epicanthus inversus syndrome) syndromes, uncontrolled severe diabetes, Cushing Syndrome, auto-immune diseases, cystic fibrosis, severe renal dysfunction)
- •Genetic/congenital disorders inducing mental retardation
研究组 & 干预措施
High risk
Conditioning therapy for bone marrow transplantation or pelvic irradiation. Fertility preservation is usually already proposed in this group of patients. No intervention.
干预措施: No intervention (Other)
Moderate/low risk
Pathologies treated with chemotherapy regimen with moderate or low risk of inducing ovarian function insufficiency: AML (Acute myeloid leukemia), osteosarcoma, Ewing sarcoma, neuroblastoma, non-Hodgkin lymphoma, Hodgkin lymphoma, soft tissue sarcoma, ALL (acute lymphoblastic hormone), Wilms tumour, retinoblastoma.
This is the study group we will compare with high risk and no risk patients. No intervention
干预措施: No intervention (Other)
No risk
Patients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment.
No intervention
干预措施: No intervention (Other)
结局指标
主要结局
AMH marker
时间窗: screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
Blood test collection for serum storage. AMH values will be compared in the different groups and correlated with the cumulative doses of alkylating agents
次要结局
- Ovarian reserve(screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old)
- Premature ovarian failure (POF)(screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old)