NCT04424615

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

May 28, 2020

Last Update Submit

October 3, 2020

Conditions

Idiopathic Granulomatous Mastitis

Outcome Measures

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.

    six months

Secondary Outcomes (1)

  • recurrence rate

    two years

Eligibility Criteria

Age10 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

patients during child bearing period

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 23091553BACKGROUND

  • 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.

    PMID: 23497626BACKGROUND

  • 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.

    PMID: 27403395BACKGROUND

Central Study Contacts

sherif bakeer, resident doctor

CONTACT

01009010275sherif.bak27@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of general surgery department

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 11, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

November 1, 2021

Last Updated

October 6, 2020

Record last verified: 2020-10