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Gene study aims to predict fertility risk after chemo

NCT ID NCT07270679

Knowledge-focused Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at whether certain genetic markers can predict which young women (ages 18-38) with breast cancer or Hodgkin lymphoma are more likely to experience early menopause and infertility after chemotherapy. Researchers will analyze stored ovarian tissue from 50 patients who had fertility preservation before treatment. The goal is to compare DNA repair genes between those who developed ovarian failure and those who did not, to better personalize fertility counseling.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors predict which patients are at higher risk of ovarian damage from chemotherapy, allowing for personalized fertility preservation counseling.
What could go wrong
This is a small, observational study (50 participants) that looks at genetic markers, not a treatment. It may not lead to immediate clinical changes, and results may not apply to all cancer types or treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Reproductive-age patients undergoing chemotherapy treatment for breast cancer or lymphoma, following ovarian biopsy and ovarian tissue cryopreservation at the Cryobank Laboratory for Ovarian Tissue Cryopreservation and Cell Cultures of the Unit of Gynecology and Human Reproductive Pathophysiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di S. Orsola

Ages

18 to 38 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Hodgkins lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Hodgkin lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    RECRUITING

    Bologna, Bologna, 40138, Italy

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