Cross immune links between breast cancer and thyroid autoimmunity and what it might mean for prognosis

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 characterization examines the relationship between breast cancer and thyroid autoimmunity by identifying women undergoing mammography and classifying them as cases or controls based on biopsy outcomes. Researchers will explore whether intra-tumoral thyroid-related immune features and microbiota patterns are associated with prognosis. The study design uses longitudinal observation to determine how thyroid autoantibody presence correlates with breast cancer outcomes, independent of initial cancer treatments. No interventional treatment changes are described in the protocol. Eligibility targets adult women ages 18-80 undergoing mammography, with exclusions for recent pregnancy, prior transplantation, or prior breast cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The study will include patients undergoing mammography (either for screening or for a suspect nodule) who meet all of the following criteria:

* signed informed consent
* age 18-80 years
* female sex

Based on the mammography results and the outcome of any biopsy performed due to the presence of breast nodule(s), patients will subsequently be categorized into cases (diagnosed with breast cancer) and controls (not diagnosed with breast cancer).

Exclusion Criteria:

Subjects who do not meet the mentioned inclusion criteria, or who meet at least one of the following exclusion criteria, will be excluded from recruitment:

* Pregnancy, within 6 months postpartum, and/or active breastfeeding
* Prior organ, bone marrow, or hematopoietic stem cell transplantation
* Prior splenectomy
* Therapy with biological agents, immunosuppressants, or immunomodulators
* History of breast cancer

Where it's running

• Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Ilaria Muller, MD, PHD
• Email: ilaria.muller@unimi.it
• Phone: +39 02 5503 3332

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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.