RecruitingNCT06667609

Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

300 participants

Start Date

Aug 28, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to evaluate the validity and reliability of the Mastitis-score (M-score) and the Breast Inflammatory Symptom Severity Index (BISSI) as measures for assessing symptom severity in non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM). This research aims to provide a valid and reliable tool for evaluating both symptom severity and treatment efficacy in NL-GLM/PDM.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • Female, age between 18 and 65 years;
  • Clinically considered as Non-Lactational mastitis;
  • Clinically and Pathologically confirmed NL-GLM/PDM;
  • Patients planning to receive treatment or observation alone;
  • Signed the informed consent form

Exclusion Criteria3

  • Patients with confirmed or suspected malignant breast tumors
  • Patients with bilateral mastitis (including those with bilateral Non-Lactational Mastitis occurring simultaneously or successively)
  • Pregnant.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERAny treatments regimen

Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences.


Locations(5)

Chaozhou Maternal and Child Health Hospital

Chaozhou, Guangdong, China

Dongguan Maternal and Child Health Care Hospital

Dongguan, Guangdong, China

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

Guangzhou, Guangdong, China

Jiangmen Maternity and Child Health Care Hospital

Jiangmen, Guangdong, China

Shenshan Medical Center, Sun Yat-sen Memorial Hospital

Shanwei, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06667609


Related Trials