Ignite Creation Date:
2024-05-06 @ 7:44 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02595255
Status:
RECRUITING
Last Update Posted:
2020-05-04
First Post:
2015-11-02
Brief Title:
AMH as a Predictor of Infertility Risk in Children With Cancer CHANCE
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
Official Title:
Antimüllerian Hormone as a Predictor of Future Infertility Risk in PrepubertalPubertal Cancer Patients
Status:
RECRUITING
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHANCE
Brief Summary:
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
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
Detailed Description:
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 andor pelvic irradiation They belong to one of these 3 groups modified from Wallace et al 2005
High risk
ModerateLow risk
No risk control group
Primary endpoint
Evaluate AMH as a potential biomarker of ovarian reserve in prepubertalpubertal girl treated by chemotherapy classified according to the AADAlkylating Agent Dose score
Secondary endpoints
Evaluate the association between the post-treatment ovarian reserve and the AMH pretreatment values in patients considered as moderate or low risk
Identify new patients group who may benefit from fertility preservation
Compare the gonadotoxicity of chemotherapy regimen according to the pubertal status
Study the relation between the AMH levels and the pubertal age menstruation cycle regularity hormonal levels FSH follicle stimulating hormone œstradiol and testosterone and bone age
Different parameters will be assessed at inclusion end of the treatment and during the follow-up every year during the first 3 years and then every 2 years until the end of the study Oncological outcome The patients will be followed up for progression and survival as per standard local practice
Ovarian reserve and function
Ovarian reserve will be evaluated based on hormonal dosages at different times of the study FSH AMH estradiol testosterone and LH luteinizing hormone Menstrual function will be evaluated by collecting information of the pubertal status spontaneous or induced puberty and menstrual cycle characteristics
Puberty evaluation
All children will have an evaluation of the TANNER pubertal stage at 9 years of age or later if 9 years old at the time of inclusion and once a year until the end of puberty when patients reach Tanner stage 5 An X-ray of the left hand and wrist will be carried out for bone age evaluation at 9-11 and 13 years old
High risk
ModerateLow risk
No risk control group
Primary endpoint
Evaluate AMH as a potential biomarker of ovarian reserve in prepubertalpubertal girl treated by chemotherapy classified according to the AADAlkylating Agent Dose score
Secondary endpoints
Evaluate the association between the post-treatment ovarian reserve and the AMH pretreatment values in patients considered as moderate or low risk
Identify new patients group who may benefit from fertility preservation
Compare the gonadotoxicity of chemotherapy regimen according to the pubertal status
Study the relation between the AMH levels and the pubertal age menstruation cycle regularity hormonal levels FSH follicle stimulating hormone œstradiol and testosterone and bone age
Different parameters will be assessed at inclusion end of the treatment and during the follow-up every year during the first 3 years and then every 2 years until the end of the study Oncological outcome The patients will be followed up for progression and survival as per standard local practice
Ovarian reserve and function
Ovarian reserve will be evaluated based on hormonal dosages at different times of the study FSH AMH estradiol testosterone and LH luteinizing hormone Menstrual function will be evaluated by collecting information of the pubertal status spontaneous or induced puberty and menstrual cycle characteristics
Puberty evaluation
All children will have an evaluation of the TANNER pubertal stage at 9 years of age or later if 9 years old at the time of inclusion and once a year until the end of puberty when patients reach Tanner stage 5 An X-ray of the left hand and wrist will be carried out for bone age evaluation at 9-11 and 13 years old
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None