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Evaluation of Individual Sensitivity to the Gonadotoxicity of Chemotherapy in Young Patients With Breast Cancer
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 36 Years
Study Type
INTERVENTIONAL
Enrollment
73
Start Date
2019-04-01
Completion Date
2027-01
Last Updated
2025-11-20
Healthy Volunteers
No
Conditions
Interventions
Blood sample for genetic test
Patients will be genotyped for single nucleotide polymorphism previously found to be associated with age at natural menopause
Blood sample for hormonal measurement
at each visit : 2x7ml. At the end of the study hormonal measurements (AMH, P4, LH, FSH, E25)
Ovarian ultrasound scan
Ovarian ultrasound scan at follow up visits (Y1,Y1.5, Y2.5 Y3.5 Y4.5 Y5.5)
Locations (1)
Antoine Béclère Hospital
Clamart, France