Genetic markers linked to chemotherapy-related ovarian damage in women who preserved ovarian tissue before treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes cryopreserved ovarian biopsy tissue from women who preserved ovarian tissue prior to gonadotoxic chemotherapy to look for genetic changes associated with later premature ovarian insufficiency (POI). Investigators will perform genetic and molecular analyses on stored ovarian samples and link those findings to clinical outcomes and hormonal markers at least six months after treatment. People with prior gonadotoxic treatments, ongoing ovarian-suppressing hormonal therapy, or known genetic syndromes that cause POI are excluded. The aim is to identify genetic variants or tissue-level changes that correlate with loss of ovarian function and could inform future fertility-preservation decisions.

Why it matters

Who can join: the full rules

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

Where it's running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Bologna, Italy Recruiting

Study contacts

• Study coordinator: Diego Raimondo, MD
• Email: die.raimondo@gmail.com
• Phone: +393290636618

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.