Granulomatous MastitisNCT06667609
Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis
An observational study of Granulomatous Mastitis and Mastitis Chronic, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 5 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Granulomatous Mastitis, Mastitis Chronic
- What is being tested?
- Any treatments regimen
- How many people
- 320 participants
- Where
- 5 sitesChina
- Study dates
- 28 Aug 2024to 12 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female diagnosed with NL-GLM/PDM in China
Who may be able to join
- 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
Who cannot join
- Patients with confirmed or suspected malignant breast tumors
- Patients with bilateral mastitis (including those with bilateral Non-Lactational Mastitis occurring simultaneously or successively)
- Pregnant.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Dongguan Maternal and Child Health Care Hospital
Dongguan, Guangdong, 523000
Sun Yat-sen memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Jiangmen Maternity and Child Health Care Hospital
Jiangmen, Guangdong, 529051
Shenshan Medical Center, Sun Yat-sen Memorial Hospital
Shanwei, Guangdong, 516600
Department of Breast Oncology, Lianjiang People's Hospital
Zhanjiang, Guangdong, 524400
About this study
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.
Read the detailed description
Non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM) are inflammatory breast diseases with unclear etiology, usually manifested as palpable breast mass, accompanied by breast pain and abscesses, erythema or fistula formation. There is no well-recognized assessment tool for evaluating the symptom severity and treatment efficacy of NL-GLM/PDM. In our previous studies with NL-GLM, we used the Mastitis-score (M-score) as a physician-directed measure of the symptom severity. However, there were no patient-reported outcome measure for NL-GLM/PDM. The Breast Inflammatory Symptom Severity Index(BISSI) was reported as a valid patient-reported outcome measure for lactational mastitis. Its clinical validity as a measure of Symptom Severity for NL-GLM/PDM are still unclear.
In this multicenter, prospective cohort study, we will validate the validity and reliability of the M-score, a physician-directed measure, and the Breast Inflammatory Symptom Severity Index (BISSI), a patient-reported outcome (PRO) measure, for assessing symptom severity in patients with non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM). Establishing the validity of these two approaches will facilitate the objective measurement of treatment efficacy for NL-GLM/PDM in the future.
- Conditions
- Granulomatous Mastitis, Mastitis Chronic
- Being tested
- Any treatments regimen
- Keywords
- M-score, validity, reliability
- Medical subject headings
- Granulomatous Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any treatments regimenOther
Also called Surgery, Corticosteroids, Ductal lavage, Anti-TB treatments
Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences.
| Study group | Role | What they receive |
|---|---|---|
| 1 | This is an observational study with no predefined treatments for the enrolled patients. Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences. Receives: Other: Any treatments regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater Reliability
This assesses the consistency of results from different evaluators regarding the various dimensions of the Mscore and the total M-score for the same patients at the same time.
Measured: 8 weeks
Test-Retest Reliability
This assesses the consistency of the M-score/BISSI results for the same patient at different times (within 1 week after enrollment), prior to treatment initiation and when symptoms have not changed significantly.
Measured: 8 weeks
Clinical Validity
This aims to estimate the correlation between the M-score/BISSI and its changes, and the BISSI and its changes, with traditional evaluator assessments or traditional patient self-assessments of treatment efficacy and its changes.
Measured: 8 weeks
Secondary outcomes (3)
Correlation between the M-score/BISSI with laboratory indicators
Explore the correlation between the M-score/BISSI with white blood cell counts, neutrophil counts, lymphocyte counts, neutrophil/lympocyte ratio, CRP, ESR, TNF-alpha, and IL-6.
Measured: 8 weeks
Cutoff value for M-score/BISSI to defined clinical complete remission.
Investigate the optimal cutoff value of the M-score/BISSI for defining clinical complete remission.
Measured: 8 weeks
Correlation between the M-score and BISSI scores.
Examine the correlation between the M-score and BISSI scores.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start28 Aug 2024
- Primary completion12 May 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Granulomatous MastitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Kai, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667609
- Sponsor's protocol ID
- SYSKY-2024-699-01
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If the study can be completed and the data have been collected, sharing IPD with the approval from the administrator would be feasible.
Publications
Heron E, McArdle A, Karim MN, Cooper M, Geddes D, McKenna L. Construct validity and internal consistency of the Breast Inflammatory Symptom Severity Index in lactating mothers with inflammatory breast conditions. PeerJ. 2021 Nov 16;9:e12439. doi: 10.7717/peerj.12439. eCollection 2021.
PubMed 34820185Chen X, Huang H, Huang H, Yong J, Zhu L, Chen Q, Tan L, Zeng Y, Yang Y, Zhao J, Rao N, Ding L, Wu W, Li Y, Gui X, Ye L, Xu Y, Jiang Y, Su L, Xiao Q, Cai X, Hu T, Tan C, Liu Q, Liu S, Zhao J, Wang Y, Yu F, Zhang J, Li S, Chen K. Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial. Nat Commun. 2024 Oct 23;15(1):9144. doi: 10.1038/s41467-024-53143-2.
PubMed 39443446
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis
- ClinicalTrials.gov ID
- NCT06667609
- Acronym / sponsor ID
- SYSKY-2024-699-01
- Conditions
- Granulomatous Mastitis, Mastitis Chronic
- Keywords
- M-score, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM) are inflammatory breast diseases with unclear etiology, usually manifested as palpable breast mass, accompanied by breast pain and abscesses, erythema or fistula formation. There is no well-recognized assessment tool for evaluating the symptom severity and treatment efficacy of NL-GLM/PDM. In our previous studies with NL-GLM, we used the Mastitis-score (M-score) as a physician-directed measure of the symptom severity. However, there were no patient-reported outcome measure for NL-GLM/PDM. The Breast Inflammatory Symptom Severity Index(BISSI) was reported as a valid patient-reported outcome measure for lactational mastitis. Its clinical validity as a measure of Symptom Severity for NL-GLM/PDM are still unclear.
In this multicenter, prospective cohort study, we will validate the validity and reliability of the M-score, a physician-directed measure, and the Breast Inflammatory Symptom Severity Index (BISSI), a patient-reported outcome (PRO) measure, for assessing symptom severity in patients with non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM). Establishing the validity of these two approaches will facilitate the objective measurement of treatment efficacy for NL-GLM/PDM in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Any treatments regimenThis is an observational study with no predefined treatments for the enrolled patients. Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female diagnosed with NL-GLM/PDM in China
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with confirmed or suspected malignant breast tumors
- Patients with bilateral mastitis (including those with bilateral Non-Lactational Mastitis occurring simultaneously or successively)
- Pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any treatments regimenAlso: Surgery, Corticosteroids, Ductal lavage, Anti-TB treatmentsParticipants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences. | Other | 1 |
Primary outcome
Inter-rater Reliability
Time frame: 8 weeks
This assesses the consistency of results from different evaluators regarding the various dimensions of the Mscore and the total M-score for the same patients at the same time.
Test-Retest Reliability
Time frame: 8 weeks
This assesses the consistency of the M-score/BISSI results for the same patient at different times (within 1 week after enrollment), prior to treatment initiation and when symptoms have not changed significantly.
Clinical Validity
Time frame: 8 weeks
This aims to estimate the correlation between the M-score/BISSI and its changes, and the BISSI and its changes, with traditional evaluator assessments or traditional patient self-assessments of treatment efficacy and its changes.
3 secondary outcomes
Correlation between the M-score/BISSI with laboratory indicators
Time frame: 8 weeks
Cutoff value for M-score/BISSI to defined clinical complete remission.
Time frame: 8 weeks
Correlation between the M-score and BISSI scores.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Results publication: PubMed 34820185Heron E, McArdle A, Karim MN, Cooper M, Geddes D, McKenna L. Construct validity and internal consistency of the Breast Inflammatory Symptom Severity Index in lactating mothers with inflammatory breast conditions. PeerJ. 2021 Nov 16;9:e12439. doi: 10.7717/peerj.12439. eCollection 2021.
- Results publication: PubMed 39443446Chen X, Huang H, Huang H, Yong J, Zhu L, Chen Q, Tan L, Zeng Y, Yang Y, Zhao J, Rao N, Ding L, Wu W, Li Y, Gui X, Ye L, Xu Y, Jiang Y, Su L, Xiao Q, Cai X, Hu T, Tan C, Liu Q, Liu S, Zhao J, Wang Y, Yu F, Zhang J, Li S, Chen K. Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial. Nat Commun. 2024 Oct 23;15(1):9144. doi: 10.1038/s41467-024-53143-2.
- Individual participant dataSharing planned: Undecided. If the study can be completed and the data have been collected, sharing IPD with the approval from the administrator would be feasible.
Related trials for Granulomatous Mastitis
RecruitingObservational study
GRAnulomatous MAstitis REGistry Study
Idiopathic Granulomatous Mastitis, Granulomatous Mastitis
Not yet recruitingPhase 1/2
Tocilizumab for the Treatment of Refractory Granulomatous Lobular Mastitis
Granulomatous Lobular Mastitis, Granulomatous Mastitis
Not yet recruiting
Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastiti
Plasmacytic Mastitis, Granulomatous Lobular Mastitis
Not yet recruitingPhase 1/2
Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis
Granulomatous Mastitis
Not yet recruitingPhase 1
Steroid Injection in Idiopathic Granulomatous Mastitis
Idiopathic Granulomatous Mastitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Granulomatous Mastitis and Mastitis Chronic, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater Reliability (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06667609, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.