Cancer Clinical Trial
— PRESOVOfficial title:
Assessment of the Effect of a Co-treatment With GnRH Analogs on the Ovarian Reserve in Adolescents and Young Women Treated With Alkylating Agents for Cancer
Verified date | December 2019 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the efficacy of a temporary ovarian suppression obtained by administration of a gonadotropin releasing hormone agonist during alkylating agents containing chemotherapy on ovarian reserve assessed by Anti-Müllerian hormone (AMH) serum levels in adolescents and young women with cancer.
Status | Active, not recruiting |
Enrollment | 11 |
Est. completion date | February 2021 |
Est. primary completion date | February 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 12 Years to 25 Years |
Eligibility |
Inclusion Criteria: - Female aged 12 to 25 years - Puberty Tanner 2 or more - Diagnosis of cancer: Sarcoma, Ewing, Osteosarcoma, Lymphoma - Chemotherapy protocol with alkylating agents at an intermediate ovarian toxicity risk (Cyclophosphamide 6 g/m2, Ifosfamide 50 g/m2, Procarbazine 4 g/m2, Lomustine 350 mg/m2 or Melphalan 140 mg/m2 or a combination of these drugs). - All patients with an osteosarcoma, Ewing sarcoma excepted pelvic localisation, Hodgkin lymphoma treatment group III (stages II B, III B and IV), B cell lymphoma group C, rhabdomyosarcoma treated with at least 8 Ifosfamide Vincristin Actinomycin (IVA) courses, synoviosarcoma group II T>5 cm and group III, adult type sarcoma group I and II T>5 cm and group III. - Before starting any chemotherapy - Covered by a medical insurance Exclusion Criteria: - Prepubertal - Pregnant - Planned brain or pelvic radiotherapy - Planned stem cell transplantation - Ovariectomy - Having already received chemotherapy with alkylating agents - Hypersensitivity to any component of GnRHa |
Country | Name | City | State |
---|---|---|---|
France | AP-HP, Bicêtre Hospital | Le Kremlin Bicêtre |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variation in AMH serum levels between both groups | Centralised hormonal dosages | at 24 months | |
Secondary | Number of patients with AMH serum levels < 5th percentile in each group | at 24 months | ||
Secondary | Intra-patient variation in AMH serum levels between groups | Centralised hormonal dosages and study of potential factors associated with the efficacy of GnRHa co-treatment in preventing ovarian reserve loss (if there is one) | up to 36 months | |
Secondary | Antral Follicular Count (AFC) on ultrasound between the 2 groups | centralised blind evaluation by an independent reader on compact disc (CD) registration of AFC | at month 24 | |
Secondary | Delay of resumption of menses between the 2 groups | Comparison of delay of resumption of menses between the 2 groups | up to the end of the follow up (an average of 3 years) | |
Secondary | Levels of markers of ovarian reserve: AMH, Follicle-stimulating hormone (FSH), Estradiol between groups | Centralised hormon dosage | at months 12, 24 and 36 | |
Secondary | Pregnancy rate in the 2 groups | up to the end of the follow up (an average of 3 years) | ||
Secondary | Adverse events related to Triptorelin co-treatment | up to the end of the follow up (an average of 3 years) | ||
Secondary | Relative change in Bone Mass Density (BMD) of the lumbar spine, left femoral neck and whole body in the 2 groups | centralised blind evaluation by an independent reader on CD registration of BMD assessed by dual-energy X-ray absorptiometry | at the baseline and at month 12 and month 36 |
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