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Can thyroid autoimmunity improve breast cancer prognosis?

NCT ID NCT07870148

Knowledge-focused Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 13, 2026 · Last updated Oct 14, 2026 · Updated 1 time

Summary

Researchers are tracking 496 women, some with breast cancer and some without, to see whether having an autoimmune thyroid condition affects breast cancer outcomes. Over five years, they will collect blood, stool, and neck lymph node samples to measure thyroid autoantibodies, look for thyroid proteins in tumors, and study immune cells and gut bacteria. The goal is to understand if thyroid autoimmunity could serve as a marker for better prognosis or lead to new treatments.

What this could mean

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

Active substance
ultrasound-guided fine needle aspiration of thyroid and neck lymph nodes
What this could lead to
If the link holds, thyroid autoantibodies or tumor TPO markers could become routine tests for breast cancer prognosis, and TPO-targeted immunotherapy or microbiome treatments might be developed.
What could go wrong
This is an observational study, so it can show associations but not prove cause and effect. The findings may not apply to other groups, and fine needle aspiration carries small risks of bleeding or infection.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 496 people

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

Started

May 2024

Expected to finish

Dec 2029

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.

Ages

18 to 80 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: 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

How to take part

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  1. The places running it

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  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

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

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