AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)
NCT ID: NCT02595255
Last Updated: 2020-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
275 participants
OBSERVATIONAL
2014-04-30
2036-12-31
Brief Summary
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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.
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Detailed Description
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* 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:
* 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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High risk
Conditioning therapy for bone marrow transplantation or pelvic irradiation. Fertility preservation is usually already proposed in this group of patients. No intervention.
No intervention
No intervention
Moderate/low risk
Pathologies treated with chemotherapy regimen with moderate or low risk of inducing ovarian function insufficiency: AML (Acute myeloide 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
No intervention
No intervention
No risk
Patients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment.
No intervention
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
3 Years
14 Years
FEMALE
No
Sponsors
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Queen Fabiola Children's University Hospital
OTHER
Erasme University Hospital
OTHER
Responsible Party
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Principal Investigators
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Isabelle Demeestere, PhD
Role: STUDY_DIRECTOR
Erasme ULB- Belgium
Alina Ferster
Role: PRINCIPAL_INVESTIGATOR
Queen Fabiola children's university hospital- Belgium
Christine Decanter
Role: PRINCIPAL_INVESTIGATOR
CHRU Lille, France
Locations
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Centre Hospitalier Chrétien (CHC)- Clinique de l'espérance
Montegnée, Liège, Belgium
Universitair Ziekenhuis Antwerpen
Antwerp, , Belgium
Hôpital Universitaire Reine Fabiola (HUDERF)
Brussels, , Belgium
Universitair Ziekenhuis Brussels
Brussels, , Belgium
UZ-Gent
Ghent, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Centre Hospitalier Régional (CHR)-Citadelle
Liège, , Belgium
Centre Oscar Lambret
Lille, , France
CHRU Lille-Hôpital Jeanne de Flandre
Lille, , France
Hôpital Robert Debré
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Brougham MF, Crofton PM, Johnson EJ, Evans N, Anderson RA, Wallace WH. Anti-Mullerian hormone is a marker of gonadotoxicity in pre- and postpubertal girls treated for cancer: a prospective study. J Clin Endocrinol Metab. 2012 Jun;97(6):2059-67. doi: 10.1210/jc.2011-3180. Epub 2012 Apr 3.
Wallace WH, Smith AG, Kelsey TW, Edgar AE, Anderson RA. Fertility preservation for girls and young women with cancer: population-based validation of criteria for ovarian tissue cryopreservation. Lancet Oncol. 2014 Sep;15(10):1129-36. doi: 10.1016/S1470-2045(14)70334-1. Epub 2014 Aug 14.
Demeestere I, Simon P, Dedeken L, Moffa F, Tsepelidis S, Brachet C, Delbaere A, Devreker F, Ferster A. Live birth after autograft of ovarian tissue cryopreserved during childhood. Hum Reprod. 2015 Sep;30(9):2107-9. doi: 10.1093/humrep/dev128. Epub 2015 Jun 9.
Imbert R, Moffa F, Tsepelidis S, Simon P, Delbaere A, Devreker F, Dechene J, Ferster A, Veys I, Fastrez M, Englert Y, Demeestere I. Safety and usefulness of cryopreservation of ovarian tissue to preserve fertility: a 12-year retrospective analysis. Hum Reprod. 2014 Sep;29(9):1931-40. doi: 10.1093/humrep/deu158. Epub 2014 Jun 22.
Other Identifiers
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CHANCE (CHildren, Amh, caNCEr)
Identifier Type: -
Identifier Source: org_study_id
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