Evaluating symptom assessment methods for non-lactational mastitis
Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis
This study is testing two ways to measure how bad symptoms are for people with non-lactational mastitis to find a reliable method that helps track their condition and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 3 sites (Chaozhou, Guangdong and 2 other locations) |
| Trial ID | NCT06667609 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the validity and reliability of two symptom severity assessment tools, the Mastitis-score (M-score) and the Breast Inflammatory Symptom Severity Index (BISSI), specifically for non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM). It will involve a multicenter, prospective cohort design where both physician-directed and patient-reported measures will be evaluated. The goal is to establish a reliable method for measuring symptom severity and treatment efficacy in patients suffering from this condition, which currently lacks standardized assessment tools.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 65 who have clinically and pathologically confirmed non-lactational granulomatous lobular/periductal mastitis.
Not a fit: Patients with confirmed or suspected malignant breast tumors or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated tool for better assessing and managing symptoms in patients with non-lactational mastitis.
How similar studies have performed: While the M-score has been previously used, the BISSI's clinical validity for NL-GLM/PDM is still unclear, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chaozhou, Guangdong and 2 other locations
- Chaozhou Maternal and Child Health Hospital — Chaozhou, Guangdong, China (Recruiting)
- Sun Yat-sen memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
- Jiangmen Maternity and Child Health Care Hospital — Jiangmen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Kai Chen
- Email: chenkai23@mail.sysu.edu.cn
- Phone: 86-20-34070463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.