Last reviewed · How we verify
NCT05361629: IGM-COMBO
The Effect of the Combination of Excision and Intraoperative Steroid Administration in Idiopathic Granulomatous Mastitis
NA trial testing Intralesional steroid administration in Idiopathic Granulomatous Mastitis in 150 participants. Status unknown.
1 April 2023
Quick facts
| Lead sponsor | Baskent University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 16 April 2022 |
| Primary completion | 1 April 2023 |
| Estimated completion | 1 September 2023 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Intralesional steroid administration
- Intraoperative cavity steroid administration
Conditions studied
- Idiopathic Granulomatous Mastitis — all drugs for Idiopathic Granulomatous Mastitis →
Sponsor
Baskent University
Who can join
Adults 18 to 65, female only, with Idiopathic Granulomatous Mastitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The effect of excision and intraoperative steroid administration to the cavity in Idiopathic Granulomatous Mastitis.
Time frame: one year
The effect of the combination of excision and single dose intraoperative steroid administration to the cavity on outcome in Idiopathic Granulomatous Mastitis.
Sponsor's own description
After breast cancer, diopathic Granulomatous Mastitis (IGM) is among the breast diseases that bother patients and clinicians the most. Countries with a coast to the Mediterranean, especially our country, are the most common geography of this disease. For this reason, a significant part of the important scientific publications about IGM in the last 3-4 decades are from the countries of this geography and mainly from our country. The paradigm of whether IGM should be treated medically or surgically is still a matter of debate. Today, effective treatment results can be achieved with medical treatments, and local drug applications are finding an increasing application area in order to reduce the systemic drug level due to the side effects often seen in this process. As in the centers dealing with breast diseases intensively in our country, patients are treated in our center both by systemic and local means. Within the body of the Turkish Breast Diseases Federation, after the plans made with the employees of the leading breast centers of the International Breast Health Working Group International planned to start a recording study to observe the activity between, local treatment in the lesion without surgical treatment with systemic treatment in IGM treatment and local treatment together with surgical treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05361629
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Idiopathic Granulomatous Mastitis
Currently open trials in the same condition.
- NCT05852171 — Baricitinib in Idiopathic Granulomatous Mastitis · Phase 2 · active not recruiting
Other Baskent University trials
Trials by the same sponsor.
- NCT07521982 — Comparison of Frailty, Physical Fitness Parameters, and Irisin Levels Between Patients With Multiple Sclerosis and Healt · not yet recruiting
- NCT07202650 — THE EFFECT OF GUİDED IMAGERY ON PREMENSTRUAL SYNDROME · NA · recruiting
- NCT07394907 — The Effectiveness of Gamified Metaverse-Based Training on Patient Safety for Nursing Students · NA · not yet recruiting
- NCT07395284 — The Effect of Gamified Metaverse-Based Training on Nursing Students' Self-Efficacy and Metaverse Perception Regarding Pr · NA · not yet recruiting
- NCT07385339 — Comfort Communication Model Intervention for Burn Pain and Pain Anxiety · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05361629 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Baskent University
- Last refreshed: 3 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05361629.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing