AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)
CHANCE
Antimüllerian Hormone as a Predictor of Future Infertility Risk in Prepubertal/Pubertal Cancer Patients
1 other identifier
observational
275
2 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2014
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2036
ExpectedMay 4, 2020
April 1, 2020
7.7 years
November 2, 2015
April 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AMH marker
Blood test collection for serum storage. AMH values will be compared in the different groups and correlated with the cumulative doses of alkylating agents
screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
Secondary Outcomes (2)
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
Ovarian reserve
screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
Study Arms (3)
High risk
Conditioning therapy for bone marrow transplantation or pelvic irradiation. Fertility preservation is usually already proposed in this group of patients. 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 risk
Patients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment. No intervention
Interventions
Eligibility Criteria
The population for this trial is patients between 3 and 14 year old newly diagnosed with cancer or benign diseases treated by chemotherapy and/or pelvic irradiation with high or moderate risk of inducing premature ovarian insufficiency. The "no risk" group includes patients with chronic benign diseases (as pneumology or gastroenterology diseases, congenital hypothyroidism, growth hormone deficiency or RCIU…) or malignancies who will not receive any chemotherapy or other gonadotoxic treatment.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Centre Hospitalier Chrétien (CHC)- Clinique de l'espérance
Montegnée, Liège, 4420, Belgium
Universitair Ziekenhuis Antwerpen
Antwerp, 2650, Belgium
Hôpital Universitaire Reine Fabiola (HUDERF)
Brussels, 1020, Belgium
Universitair Ziekenhuis Brussels
Brussels, 1090, Belgium
UZ-Gent
Ghent, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Centre Hospitalier Régional (CHR)-Citadelle
Liège, 4000, Belgium
Centre Oscar Lambret
Lille, 59000, France
CHRU Lille-Hôpital Jeanne de Flandre
Lille, 59037, France
Hôpital Robert Debré
Paris, France
Related Publications (4)
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.
PMID: 22472563BACKGROUNDWallace 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.
PMID: 25130994BACKGROUNDDemeestere 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.
PMID: 26062556BACKGROUNDImbert 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.
PMID: 24958067BACKGROUND
Biospecimen
serum for hormonal assessment
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Isabelle Demeestere, PhD
Erasme ULB- Belgium
- PRINCIPAL INVESTIGATOR
Alina Ferster
Queen Fabiola children's university hospital- Belgium
- PRINCIPAL INVESTIGATOR
Christine Decanter
CHRU Lille, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2015
First Posted
November 3, 2015
Study Start
April 1, 2014
Primary Completion
December 1, 2021
Study Completion (Estimated)
December 1, 2036
Last Updated
May 4, 2020
Record last verified: 2020-04