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New mastitis symptom scales put to the test

NCT ID NCT06667609

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This study evaluates two new methods—the M-Score and BISSI—for assessing symptom severity in non-lactational mastitis, a breast inflammation condition not related to breastfeeding. Researchers will enroll 320 women aged 18-65 with confirmed non-lactational mastitis to see if these tools are reliable and valid. The goal is to give doctors better ways to track symptoms and treatment success.

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 provide doctors with reliable tools to better assess symptom severity and treatment effectiveness for non-lactational mastitis.
What could go wrong
This is an observational study focused on measurement tools, not a treatment trial. The tools may not prove accurate or useful in routine practice.

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

320 people

The number who actually took part.

Started

Aug 2024

Expected to finish

May 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

Female diagnosed with NL-GLM/PDM in China

Ages

18 to 65 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: 1. Female, age between 18 and 65 years; 2. Clinically considered as Non-Lactational mastitis; 3. Clinically and Pathologically confirmed NL-GLM/PDM; 4. Patients planning to receive treatment or observation alone; 5. Signed the informed consent form Exclusion Criteria: 1. Patients with confirmed or suspected malignant breast tumors 2. Patients with bilateral mastitis (including those with bilateral Non-Lactational Mastitis occurring simultaneously or successively) 3. Pregnant.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Chaozhou Maternal and Child Health Hospital

    Chaozhou, Guangdong, 521000, China

  • Dongguan Maternal and Child Health Care Hospital

    Dongguan, Guangdong, 523000, China

  • Jiangmen Maternity and Child Health Care Hospital

    Jiangmen, Guangdong, 529051, China

  • Shenshan Medical Center, Sun Yat-sen Memorial Hospital

    Shanwei, Guangdong, 516600, China

  • Sun Yat-sen memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120, China

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