Breast Cancer Clinical Trial
— ESIGONOfficial title:
Evaluation of Individual Sensitivity to the Gonadotoxicity of Chemotherapy in Young Patients With Breast Cancer
Verified date | October 2022 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Over the past decade, advances in diagnosis and treatments have dramatically increased the rates of cure for young patients with cancer. As a consequence, a new population of cancer survivors has emerged whose fertility is compromised after cancer therapy. Indeed, gonadotoxicity is a well-known long-term side effect of cancer treatment in young patients having survived malignant diseases. More than 80% of women of childbearing age, treated for breast cancer with standard protocol of neoadjuvant (4 cycles of 5-fluorouracile - epirubicin- cyclophosphamide (FEC) and 4 cycles of docetaxel) or adjuvant chemotherapy (3 FEC and 3 docetaxel), show an alteration of their ovarian reserve 2 years after completion of the treatment, as a result of chemotherapy-related follicular loss. Therefore, according to the extent of the follicular damages, the gonadal function may vary from moderate to severe diminished ovarian reserve (DOR) and possibly to the ultimate stage of premature ovarian insufficiency (POI). Investigators propose a multicentric and prospective study of a cohort of young women with breast cancer to evaluate whether genetic polymorphisms, previously identified as being correlated with age at menopause in the healthy population, are associated with the intensity of the follicular decline following chemotherapy in young breast cancer survivors.
Status | Active, not recruiting |
Enrollment | 73 |
Est. completion date | January 2027 |
Est. primary completion date | October 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility | Inclusion Criteria: - Age: 18 - 36 years - Diagnosis of breast cancer - BMI=30 Kg/m2 - Baseline antral Follicular count (before initiation of chemotherapy): 10-40 follicles measuring 2 - 9 mm in diameter - Regular and ovulatory menstrual cycles - Indication of neoadjuvant (4 FEC and 4 docetaxel) or adjuvant (3 FEC and 3 docetaxel) chemotherapy - Free informed and written consent, dated and signed by the patient and the investigator - Patient affiliated to the French National Social Security System Non inclusion criteria - Previous history of chemotherapy - History of ovarian surgery or endometrioma - Ovarian Polycystic Syndrome - DOR or POI before chemotherapy - Virgin patients Exclusion Criteria: - Intensification of chemotherapy |
Country | Name | City | State |
---|---|---|---|
France | Antoine Béclère Hospital | Clamart |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of ovarian reserve | is an aggregated measure of FSH, AMH serum level, Antral Follicle Count and menstrual profile : Normal ovarian reserve: persistence of menstrual cycle, FSH<40 IU/L and AMH>1.1 ng/mL or AFC>7 follicles Moderate diminished ovarian reserve : persistence of menstrual cycle, FSH<40 IU/L and 0.5=AMH=1.1 ng/mL or 5=AFC=7 follicles Severe diminished ovarian reserve : persistence of menstrual cycle and AMH<0.5 ng/mL or AFC<5 follicles Premature ovarian insufficiency is defined by amenorrhea above four months and FSH level =40 IU/L in women before 40 years. AMH serum levels and ultrasonographic evaluation of AFC will be evaluated FIVEyears after the end of chemotherapy. |
5 years after completion of chemotherapy | |
Secondary | Menstrual profile: amenorrhea, spaniomenorrhea, normal cycle length (28-35 days) | To evaluate the association between genetic polymorphisms and other parameters related to female fertility after chemotherapy such as the menstrual cycle profile. These data will be obtained from clinical interrogatory performed by medical doctors. | 5 years | |
Secondary | Pregnancy rates | These data will be obtained from clinical interrogatory performed by medical doctors. | 5 years | |
Secondary | AMH level | To assess the evolution of ovarian reserve tests at the end of chemotherapy AMH level will be performed before the initiation of chemotherapy and 6, 12, 24, 36, 48, 60 months following the end of chemotherapy. | 6, 12, 24, 36, 48, 60 months following the end of chemotherapy. | |
Secondary | Antral Follicle Count (Ultrasound evaluation) | To assess the evolution of ovarian reserve tests at the end of chemotherapy Measurements of ultrasonographic AFC will be performed before the initiation of chemotherapy and 6, 12, 24, 36, 48, 60 months following the end of chemotherapy. | 6, 12, 24, 36, 48, 60 months following the end of chemotherapy. | |
Secondary | Follicular decline (definition below) | A follicular decline will be defined as a moderate/severe DOR or a POI | 2 years after the completion of chemotherapy |
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