Idiopathic Granulomatous MastitisNCT05409586
Risk Factors and the Role of Albumin-to-globulin Ratio in Idiopathic Granulomatous Mastitis
An observational study of Idiopathic Granulomatous Mastitis, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Albumin-to-globulin ratio (AGR) is an inflammation-based index that has been shown to have a role in many cancers and inflammatory diseases. Idiopathic granulomatous mastitis (IGM) is a rare inflammatory disease of the breast with a high recurrence rate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Idiopathic Granulomatous Mastitis
- What is being tested?
- segmental mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2022to 25 May 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with IGM on pathology reports between January 2016 and March 2021
Who may be able to join
- The patients with a pathologically confirmed diagnosis of granulomatous mastitis
- Patients over the age of 18
- Female patients
Who cannot join
- Male patients
- Secondary granulomatous mastitis etiologies (tuberculous mastitis and Wegener's granulomatosis)
- Patients who do not have enough follow-up information
- Patients with missing data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Eğitim ve Araştırma Hastanesi
Samsun, 55090
About this study
Official title: Evaluating the Risk Factors and the Role of Albumin-to-globulin Ratio in Predicting Recurrence Among Patients With Idiopathic Granulomatous Mastitis
Albumin-to-globulin ratio (AGR) is an inflammation-based index that has been shown to have a role in many cancers and inflammatory diseases. Idiopathic granulomatous mastitis (IGM) is a rare inflammatory disease of the breast with a high recurrence rate. As a relatively new biomarker for inflammatory diseases, AGR's role in IGM recurrence has never been investigated in the literature. This study primarily investigates the possible risk factors for IGM recurrence and whether AGR can be used as a predictive factor.
Read the detailed description
Patients diagnosed with IGM on pathology reports between January 2016 and March 2021 were enrolled in the study and their medical records were analyzed retrospectively. The patients were divided into two groups: recurrence and non-recurrence. Clinical, demographic characteristics, and laboratory parameters were compared. The best cut-off value for significant factors in predicting recurrence was determined by receiver operating characteristic (ROC) analysis. Univariate and multivariate logistic regression analysis was used to determine the risk factors that are effective in IGM recurrence.
- Conditions
- Idiopathic Granulomatous Mastitis
- Being tested
- segmental mastectomy
- Keywords
- Idiopathic granulomatous mastitis, recurrence, albumin-to-globulin ratio, risk factors
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
segmental mastectomyProcedure or surgery
Also called Incision and Drainage
The preferred method in the treatment of some patients diagnosed with IGM
| Study group | Role | What they receive |
|---|---|---|
| no recurrence | Patients who recovered after IGM treatment and had no signs of relapse Receives: Procedure: segmental mastectomy | |
| recurrence | Patients whose symptoms reappear 3 months after IGM treatment Receives: Procedure: segmental mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGM recurrence
Recurrence was defined as the reappearance of breast complaints such as pain, mass, abscess, and fistula at the end of at least three months following remission with treatment. IGM developed in the other breast after the treatment was also accepted as a recurrent case.
Measured: within an average of 3-4 years of follow-up after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start20 Apr 2022
- Primary completion20 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Idiopathic 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
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Burak Ciftci, Samsun Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409586
- Sponsor's protocol ID
- SAMSUNERH.IGM
- Status last verified
- Jun 2022
- First submitted
- 29 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated and analyzed in this study will be available from the corresponding author on reasonable request.
Publications
Xuan Q, Yang Y, Ji H, Tang S, Zhao J, Shao J, Wang J. Combination of the preoperative albumin to globulin ratio and neutrophil to lymphocyte ratio as a novel prognostic factor in patients with triple negative breast cancer. Cancer Manag Res. 2019 May 31;11:5125-5131. doi: 10.2147/CMAR.S195324. eCollection 2019.
PubMed 31213922Uysal E, Soran A, Sezgin E; Granulomatous Mastitis Study Group. Factors related to recurrence of idiopathic granulomatous mastitis: what do we learn from a multicentre study? ANZ J Surg. 2018 Jun;88(6):635-639. doi: 10.1111/ans.14115. Epub 2017 Jul 27.
PubMed 28749045Azizi A, Prasath V, Canner J, Gharib M, Sadat Fattahi A, Naser Forghani M, Sajjadi S, Farhadi E, Vasigh M, Kaviani A, Omranipour R, Habibi M. Idiopathic granulomatous mastitis: Management and predictors of recurrence in 474 patients. Breast J. 2020 Jul;26(7):1358-1362. doi: 10.1111/tbj.13822. Epub 2020 Apr 5.
PubMed 32249491Velidedeoglu M, Kundaktepe BP, Aksan H, Uzun H. Preoperative Fibrinogen and Hematological Indexes in the Differential Diagnosis of Idiopathic Granulomatous Mastitis and Breast Cancer. Medicina (Kaunas). 2021 Jul 8;57(7):698. doi: 10.3390/medicina57070698.
PubMed 34356979Ciftci AB, Buk OF, Yemez K, Polat S, Yazicioglu IM. Risk Factors and the Role of the Albumin-to-Globulin Ratio in Predicting Recurrence Among Patients with Idiopathic Granulomatous Mastitis. J Inflamm Res. 2022 Sep 18;15:5401-5412. doi: 10.2147/JIR.S377804. eCollection 2022.
PubMed 36158516
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Risk Factors and the Role of Albumin-to-globulin Ratio in Predicting Recurrence Among Patients With Idiopathic Granulomatous Mastitis
- ClinicalTrials.gov ID
- NCT05409586
- Acronym / sponsor ID
- SAMSUNERH.IGM
- Conditions
- Idiopathic Granulomatous Mastitis
- Keywords
- Idiopathic granulomatous mastitis, recurrence, albumin-to-globulin ratio, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 8 Jun 2022 (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.
Albumin-to-globulin ratio (AGR) is an inflammation-based index that has been shown to have a role in many cancers and inflammatory diseases. Idiopathic granulomatous mastitis (IGM) is a rare inflammatory disease of the breast with a high recurrence rate. As a relatively new biomarker for inflammatory diseases, AGR's role in IGM recurrence has never been investigated in the literature. This study primarily investigates the possible risk factors for IGM recurrence and whether AGR can be used as a predictive factor.
Detailed description
Patients diagnosed with IGM on pathology reports between January 2016 and March 2021 were enrolled in the study and their medical records were analyzed retrospectively. The patients were divided into two groups: recurrence and non-recurrence. Clinical, demographic characteristics, and laboratory parameters were compared. The best cut-off value for significant factors in predicting recurrence was determined by receiver operating characteristic (ROC) analysis. Univariate and multivariate logistic regression analysis was used to determine the risk factors that are effective in IGM recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no recurrence | – | Procedure: segmental mastectomyPatients who recovered after IGM treatment and had no signs of relapse |
| recurrence | – | Procedure: segmental mastectomyPatients whose symptoms reappear 3 months after IGM treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with IGM on pathology reports between January 2016 and March 2021
Key inclusion criteria (3 listed)
- The patients with a pathologically confirmed diagnosis of granulomatous mastitis
- Patients over the age of 18
- Female patients
Key exclusion criteria (4 listed)
- Male patients
- Secondary granulomatous mastitis etiologies (tuberculous mastitis and Wegener's granulomatosis)
- Patients who do not have enough follow-up information
- Patients with missing data
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 |
|---|---|---|
| segmental mastectomyAlso: Incision and DrainageThe preferred method in the treatment of some patients diagnosed with IGM | Procedure or surgery | no recurrence, recurrence |
Primary outcome
IGM recurrence
Time frame: within an average of 3-4 years of follow-up after treatment
Recurrence was defined as the reappearance of breast complaints such as pain, mass, abscess, and fistula at the end of at least three months following remission with treatment. IGM developed in the other breast after the treatment was also accepted as a recurrent case.
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 8 Jun 2022.
- Background: PubMed 31213922Xuan Q, Yang Y, Ji H, Tang S, Zhao J, Shao J, Wang J. Combination of the preoperative albumin to globulin ratio and neutrophil to lymphocyte ratio as a novel prognostic factor in patients with triple negative breast cancer. Cancer Manag Res. 2019 May 31;11:5125-5131. doi: 10.2147/CMAR.S195324. eCollection 2019.
- Results publication: PubMed 28749045Uysal E, Soran A, Sezgin E; Granulomatous Mastitis Study Group. Factors related to recurrence of idiopathic granulomatous mastitis: what do we learn from a multicentre study? ANZ J Surg. 2018 Jun;88(6):635-639. doi: 10.1111/ans.14115. Epub 2017 Jul 27.
- Results publication: PubMed 32249491Azizi A, Prasath V, Canner J, Gharib M, Sadat Fattahi A, Naser Forghani M, Sajjadi S, Farhadi E, Vasigh M, Kaviani A, Omranipour R, Habibi M. Idiopathic granulomatous mastitis: Management and predictors of recurrence in 474 patients. Breast J. 2020 Jul;26(7):1358-1362. doi: 10.1111/tbj.13822. Epub 2020 Apr 5.
- Results publication: PubMed 34356979Velidedeoglu M, Kundaktepe BP, Aksan H, Uzun H. Preoperative Fibrinogen and Hematological Indexes in the Differential Diagnosis of Idiopathic Granulomatous Mastitis and Breast Cancer. Medicina (Kaunas). 2021 Jul 8;57(7):698. doi: 10.3390/medicina57070698.
- Derived from this study: PubMed 36158516Ciftci AB, Buk OF, Yemez K, Polat S, Yazicioglu IM. Risk Factors and the Role of the Albumin-to-Globulin Ratio in Predicting Recurrence Among Patients with Idiopathic Granulomatous Mastitis. J Inflamm Res. 2022 Sep 18;15:5401-5412. doi: 10.2147/JIR.S377804. eCollection 2022.
- Individual participant dataSharing planned: Undecided. The datasets generated and analyzed in this study will be available from the corresponding author on reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Granulomatous Mastitis, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
IGM recurrence (time frame: within an average of 3-4 years of follow-up after treatment). 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 NCT05409586, which also lists 5 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 8 Jun 2022.