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AzTrials

Idiopathic Granulomatous MastitisIGMNCT04424615

Idiopathic Granulomatous Mastitis

An observational study of Idiopathic Granulomatous Mastitis, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Assessment of incidence, diagnosis and treatment of idiopathic granulomatous mastitis in Assiut university hospital Read more about this study

Who is it for?
Ages 10 to 45 years, women only
Conditions the study is for
Idiopathic Granulomatous Mastitis
How many people
30 participants
Where
No sites listed yet
Study dates
Oct 2020to Nov 2021
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 10 to 45 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Study population: patients during child bearing period

Who may be able to join

  • 1- patients proved idiopathic granulomatous mastitis by histopathological examinaton 2 - Patients during child bearing period

Who cannot join

  • - tuberculous mastitis, ductectasi, fat necrosis, fungal infection, and sarcoidosis were excluded.
  • - post-surgical granulomatous reactions against foreign material

Trial locations and contacts

No sites are listed yet.

sherif bakeer, resident doctor contact

01009010275

sherif.bak27@gmail.com

About this study

Assessment of incidence, diagnosis and treatment of idiopathic granulomatous mastitis in Assiut university hospital

Read the detailed description

Idiopathic granulomatous mastitis is an uncommon, benign and chronic inflammatory breast disease that mainly involves women of childbearing age . The disease, was first described by Kessler and Wollock in 1972 .Although it is a benign condition, it is important from different points of view: it poses a diagnostic and treatment dilemma , also, it clinically and mammographically mimics breast cancer, especially inflammatory type . On the other hand, due to lack of a definitive treatment plan, complications of empiric treatment, such as allergic reaction to antibiotics and poor cosmetic procedures result in following repeated surgical interventions which threaten the patients . In fact, the etiology of IGM is unknown but some factors have been stated including reaction to chemical materials such as oral contraceptive pills, infectious disease, autoimmune diseases and immunologic response formilk leakage from the breast's lobule . On the other hand, some conditions such as pregnancy, breast feeding, hyper prolactinemia, galactorrhea, and alpha 1 antitrypsin deficiency have been associated with the risk of the disease . Infection with corynebacterium kroppenstedtii has been suggested but is unconfirmed . The final word about etiology is that although the cause of the disease is unknown the general consensus is that reproductive age, recent pregnancy, breast feeding and history of oral contraceptive pills use are the most associated conditions with the disease, as shown in finding. The most common presenting sign is a defined hard lump of the breast. As the disease progresses nipple inversion, peau d'orange, tumorous in duration, ulcer and fistula can occur that can easily be mistaken for cancer . The most common reported ultrasound (U/S) findings are: an irregular hypo echoic finding that connects with the tubular hypo echo area and parenchymal heterogeneity and an area of mixed echo pattern with parenchymal deformity, both of which can lead to diagnosis of malignant changes . Common findings in mammography imaging are asymmetric diffuse and skin thickness . As mentioned previously, neither U/S nor mammography can differentiate IGM from malignant or other benign lesions, especially inflammatory breast cancers . Because of U/S and mammographic failure, some authors suggested MRI in diagnosis of IGM, but studies have shown that MRI does not provide additional findings for differentiation of IGM from breast cancer. In view of the non-definitive clinical and imaging findings, histopathology is the cornerstone of definitive diagnosis . It must be mentioned that FNA cannot confidently differentiate IGM and histopathological examination remains as the cornerstone . Some studies obtained different results in terms of the treatment of these patients that suggested corticosteroids and methotrexate with surgery or treatment with corticosteroid and azithromycin, and administration of steroids in lesions in these patients .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical response rate

    The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.

    clinical response rate [ Time Frame: six months ] The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.

    Measured: six months

Secondary outcomes (1)
  1. recurrence rate

    granulomatous mastitis recurrence

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study startOct 2020 (estimated)
  3. Primary completionOct 2021 (estimated)
  4. Study completionNov 2021 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04424615
Sponsor's protocol ID
IGM
Acronym
IGM
Status last verified
Oct 2020
First submitted
28 May 2020
Last updated
6 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bellavia M, Damiano G, Palumbo VD, Spinelli G, Tomasello G, Marrazzo A, Ficarella S, Bruno A, Sammartano A, Fiorentini T, Scio A, Maione C, Lo Monte AI. Granulomatous Mastitis during Chronic Antidepressant Therapy: Is It Possible a Conservative Therapeutic Approach? J Breast Cancer. 2012 Sep;15(3):371-2. doi: 10.4048/jbc.2012.15.3.371. Epub 2012 Sep 28.

    PubMed 23091553
  • Garcia-Rodiguez JA, Pattullo A. Idiopathic granulomatous mastitis: a mimicking disease in a pregnant woman: a case report. BMC Res Notes. 2013 Mar 14;6:95. doi: 10.1186/1756-0500-6-95.

    PubMed 23497626
  • Kalayci TO, Koruyucu MB, Apaydin M, Etit D, Varer M. Idiopathic Granulomatous Mastitis Associated with Erythema Nodosum. Balkan Med J. 2016 Mar;33(2):228-31. doi: 10.5152/balkanmedj.2015.150089. Epub 2016 Mar 1.

    PubMed 27403395

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Granulomatous Mastitis, run by Assiut University.

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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact sherif bakeer, resident doctor (01009010275, sherif.bak27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical response rate (time frame: six months). 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 NCT04424615, which also lists 3 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 6 Oct 2020.

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