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Status unknownNCT04424615IGMUpdated Oct 6, 2020

Idiopathic Granulomatous Mastitis

An observational study in Idiopathic Granulomatous Mastitis, sponsored by Assiut University. Status unknown. Open to female participants aged 10 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-10-06.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
10 Years to 45 Years
Sex
Female
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Study summary

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 .

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Conditions studied

  • Idiopathic Granulomatous Mastitis
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Who can participate

Ages eligible
10 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients during child bearing period

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  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.

    Time frame: six months

Secondary outcomes

  1. recurrence rate

    granulomatous mastitis recurrence

    Time frame: two years

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗
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Registry details

Key details

Study ID
NCT04424615
Lead sponsor
Assiut University
Responsible party
Sherif M Bakeer (head of general surgery department, Assiut University) — Principal investigator
First posted
Jun 11, 2020
Start date
Oct 2020 (estimated)
Primary completion
Oct 2021 (estimated)
Completion
Nov 2021 (estimated)
Last update
Oct 6, 2020

Study contacts

sherif bakeer, resident doctor
Contact
sherif.bak27@gmail.com
01009010275

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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