An interventional study of Ductal lavage and Corticosteroid therapy in Granulomatous Mastitis, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Completed at 2 sites in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
Among 10 studies in Granulomatous Mastitis with a site in China — 2 open to participants now, 3 under way, none of them phase 3. Granulomatous Mastitis · China.
Among the 10 studies in Granulomatous Mastitis with a site in China, this one is one of 3 that started in 2019, is one of 3 with no phase, and was the 2nd registered.
22 studies on the registry are indexed under Granulomatous Mastitis; 7 are open to participants now.
Browse Granulomatous Mastitis studies →2 of the 10 studies in Granulomatous Mastitis with a site in China are open now. Recruiting first, the newest first:
Hubei Cancer Hospital · Sites in China
Ages 18+ · Women only
Wuhan University · Sites in China
Ages 18–60 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 2 Granulomatous Mastitis studies recruiting now, 2 set no upper age limit and none stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years to 65 Years · female · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 3 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 140 is above the median of 61 across 12 interventional studies indexed under Granulomatous Mastitis.
Median enrollment 100 across the 6 interventional studies, 210 across the 4 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 6 most frequent:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University has 4 studies filed under Granulomatous Mastitis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Granulomatous Mastitis with a site in China, from their registry updates:
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A single-arm, proof-of-concept trial has shown the safety and efficacy of ductal lavage as a treatment for idiopathic granulomatous mastitis patients (Manuscript accepted in Journal of Surgical Research 2018). In this multicenter, randomized, open-labeled, non-inferior trial, the investigators are going to enroll eligible granulomatous mastitis patients and randomized them into ductal lavage versus. corticosteroids therapy group. The primary endpoint of this study is the complete clinical response rate at 1 year after the enrollment. The aim of this study is to provide evidence for the management of idiopathic granulomatous mastitis patients .
Non-lactational mastitis (NLM) consists of a broad spectrum of inflammatory breast diseases. Among them, periductal mastitis and idiopathic granulomatous mastitis(IGM) are the most commonly encountered in clinical practice. IGM can be diagnosed when all possible causes of granulomatous diseases (known mycobacterial or fungal infection, Wegener granulomatosis, sarcoidosis, etc.) are excluded. There is no consensus on the standard treatment of IGM patients. Surgery, oral corticosteroids, topical steroids, immunosuppressive therapy, and observation alone were all proposed as the treatment for IGM patients. However, all of the evidences are derived from retrospective studies. In a previous study, the investigators conducted a single-arm, proof-of-concept trial that showed the safety and efficacy of ductal lavage as a treatment for IGM patients. Ductal lavage is possible to spare the patients from corticosteroids therapy and or surgery. To further address this issue, the investigators are going to conduct this multicenter, randomized, open-labeled, non-inferior trial, to compare the efficacy and safety of ductal lavage and corticosteroids therapy. The aim of this study is to provide evidence for the management of IGM patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ductal lavage and breast massage for two weeks.
Procedure: Ductal lavage
Oral corticosteroids therapy for 6 months.
Drug: Corticosteroid therapy
The patients received ductal lavage and breast massage every other day for two weeks. We used lidocaine (1%) for local anesthesia around the nipple. We used a lacrimal probe to identify 4-5 openings in the lactiferous ducts on the nipple and inserted the infusion cannula (21-23G). A total of 25ml of irrigation solution (5 ml of 2% lidocaine, 40 mg of triamcinolone acetonide, 20 ml of 0.9% saline and 1.0 g of ceftriaxone) was pumped into the ducts over 20-25 minutes. The patient returned to the clinic the next day for breast massage, and the cycle was repeated for two weeks.
Methylprednisolone(Common brand names: Medrol) or prednisone 20-40mg, qd for two weeks, then temper the dose gradually, and then 20mg qd for maintenance (The total duration of the treatment is 6 months).
Complete Clinical Response(cCR)
The proportion of patients that achieve M-score \<=1 at 1 year after the treatment.
Time frame: 1 year since randomization
Time to cCR
The median time to cCR since the randomization.
Time frame: 1 year since randomization
Treatment failure (TF) rate
The proportion of patients with TF at 1 year since the randomization. The TF status is defined as the following: 1. If the patient has M-score\>=6 before randomization, TF is defined as the M-score still remains \>=6 at one month since the randomization. 2. If the patient has M-score between 4 and 5 before randomization, TF is defined as the M-score still remains at \>=4, and never have been lower than 4. 3. If the patient has M-score\<4 before randomization, and never reaches cCR since randomization, and during follow-up, the M-score is found to be \>5 and last for one month.
Time frame: 1 year since randomization
Relapse rate
The proportion of patients that had M-score\>4 among those patients who achieved cCR.
Time frame: 1 year since randomization
Adverse events
Pre-defined and any other unexpected adverse events would be recorded and compared between the two arms.
Time frame: 1 year since randomization
Protocol compliance rate
The proportion of patients who received the treatment protocol.
Time frame: 1 year since randomization
Plan to share: No — The study protocol and the raw and clean data for analysis will be shared among the participated researchers. Non-researchers could obtain relevant informations from the researchers upon reasonable requests.
Ran from Apr 2019 to primary completion in Apr 2023, 48 months.
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University →