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Genetic Markers of Susceptibility to Chemotherapy-induced Ovarian Damage in Cancer Patients Undergoing Ovarian Biopsy for Cryopreservation.

Recruitingn/aAges 18 Years - 38 YearsFemaleIRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT07270679 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Italian Cancer Registry data show a steady increase in the number of cancer survivors due to advances in treatment. However, these treatments can impair ovarian function, causing premature ovarian insufficiency (POI). Women with POI may experience vasomotor symptoms, infertility, psychological distress, and a significant reduction in quality of life. POI typically occurs before age 40 and is characterized by irregular menstruation and biochemical alterations (elevated gonadotropins and low estradiol). Chronic estrogen deficiency in POI is associated with increased risks of cardiovascular disease, cognitive decline, osteoporosis, psychological issues, and reproductive dysfunction. Preliminary studies suggest that chemotherapy-induced POI results from genetic changes in ovarian tissue, indicating a crucial role of genetic variations in individual susceptibility. Incidence rates of POI var

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 and ≤ 38 years at the time of cryopreservation * Patient diagnosed with breast cancer or lymphoma, who underwent ovarian biopsy and cryopreservation of ovarian tissue prior to the initiation of gonadotoxic treatment * Gonadotoxic therapy completed at least 6 months prior * Written informed consent obtained for participation in the study and for the processing of personal, sensitive, and genetic data Exclusion Criteria: * Patients with a history of gonadotoxic treatments prior to ovarian tissue cryopreservation * Patients undergoing hormonal therapy that suppresses ovarian function (e.g., GnRH analogs) * Presence of other conditions potentially responsible for premature ovarian insufficiency \[e.g., BRCA1 and BRCA2 mutations, Li-Fraumeni syndrome, Bloom syndrome, Fanconi anemia, Fragile X syndrome, Cowden syndrome, Lynch syndrome (Hereditary Non-Polyposis Colorectal Cancer - HNPCC), Ataxia-Telangiectasia\] * Family history of premature ovarian insufficiency
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What it tests

  • Not listed
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Where

1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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