Evaluation of Individual Sensitivity to the Gonadotoxicity of Chemotherapy in Young Patients With Breast Cancer (ESIGON)
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|ClinicalTrials.gov Identifier: NCT03731845|
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : October 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Genetic: Blood sample for genetic test Biological: Blood sample for hormonal measurement Other: Ovarian ultrasound scan||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Individual Sensitivity to the Gonadotoxicity of Chemotherapy in Young Patients With Breast Cancer|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||October 2026|
|Estimated Study Completion Date :||January 2027|
Genetic: Blood sample for genetic test
Patients will be genotyped for single nucleotide polymorphism previously found to be associated with age at natural menopause
Biological: Blood sample for hormonal measurement
at each visit : 2x7ml. At the end of the study hormonal measurements (AMH, P4, LH, FSH, E25)
Other: Ovarian ultrasound scan
Ovarian ultrasound scan at follow up visits (Y1,Y1.5, Y2.5 Y3.5 Y4.5 Y5.5)
- Assessment of ovarian reserve [ Time Frame: 5 years after completion of chemotherapy ]
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.
- Menstrual profile: amenorrhea, spaniomenorrhea, normal cycle length (28-35 days) [ Time Frame: 5 years ]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.
- Pregnancy rates [ Time Frame: 5 years ]These data will be obtained from clinical interrogatory performed by medical doctors.
- AMH level [ Time Frame: 6, 12, 24, 36, 48, 60 months following the end of chemotherapy. ]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.
- Antral Follicle Count (Ultrasound evaluation) [ Time Frame: 6, 12, 24, 36, 48, 60 months following the end of chemotherapy. ]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.
- Follicular decline (definition below) [ Time Frame: 2 years after the completion of chemotherapy ]A follicular decline will be defined as a moderate/severe DOR or a POI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731845
|Contact: Charlotte SONIGO, MD||01 45 37 40 firstname.lastname@example.org|
|Contact: Marie GODARD||00 33 1 58 41 34 email@example.com|
|Antoine Béclère Hospital||Recruiting|
|Clamart, France, 92140|
|Contact: Charlotte SONIGO, MD firstname.lastname@example.org|
|Principal Investigator:||Charlotte SONIGO, MD||Assistance Publique - Hôpitaux de Paris|
|Study Chair:||Michael Grynberg, MD, PhD||Assistance Publique - Hôpitaux de Paris|