Breast Cancer SurgeryIDPNCT06970561
Analysis of Recurrence of Intraductal Papilloma Treated With Vacuum-assisted Rotary Excision
An observational study of Breast Cancer Surgery and Benign Breast Tumors, run by Wuhan Children's Hospital at 1 site in China.
Trial summary
To study the postoperative recurrence of intraductal papillomas (IDP) treated with ultrasound-guided vacuum-assisted excision (VAE), and to investigate the effect of different lesion characteristics on recurrence. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer Surgery, Benign Breast Tumors
- What is being tested?
- enlarged resection
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2020to 1 Sep 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: IDP patients who underwent ultrasound-guided VAE treatment from January 2020 to August 2024 in Zhongnan Hospital of Wu han University.
Who may be able to join
- IDP was diagnosed pathologically after VAE treatment
- the tumor was a solitary lesion with the margin >1cm from the nipple and the longest diameter of the tumor <3cm
- it was not associated with other breast diseases
Who cannot join
- previous ductal breast surgery
- abnormal coagulation function or taking anticoagulant drugs .recent or current use of hormonal or psychotropic drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Factors Associated With Postoperative Recurrence of Intraductal Papilloma of the Breast Treated With Ultrasound-guided Vacuum-assisted Rotary Excision
To study the postoperative recurrence of intraductal papillomas (IDP) treated with ultrasound-guided vacuum-assisted excision (VAE), and to investigate the effect of different lesion characteristics on recurrence.
Read the detailed description
106 patients with IDP with or without atypical ductal hyperplasia (ADH) treated with ultrasound-guided VAE at Zhongnan Hospital of Wuhan University from January 2020 to August 2024 were selected for the study, and the postoperative conditions of the patients were sorted out and followed up to analyze the characteristics of the lesions and to determine the relevant factors that affected the postoperative recurrence.
- Conditions
- Breast Cancer Surgery, Benign Breast Tumors
- Being tested
- enlarged resection
- Keywords
- intraductal papilloma of the breast, treatment, vacuum-assisted rotational excision therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enlarged resectionProcedure or surgery
Also called secondary enlarged resection
patients underwent secondary enlarged resection within 1 month after the diagnosis of IDP combined with ADH,
| Study group | Role | What they receive |
|---|---|---|
| recurrent | Patients who relapsed after receiving ultrasound-guided vacuum-assisted rotary excision Receives: Procedure: enlarged resection | |
| non-recurrent | Patients who did not relapsed after receiving ultrasound-guided vacuum-assisted rotary excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
Recurrence was defined as the appearance of a lesion within 2-3 cm of the original surgical area with corresponding clinical manifestations, such as nipple discharge and imaging support, which was later pathologically confirmed as IDP
Measured: The cut-off date for follow-up was September 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start6 Jan 2020
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hu, Wuhan Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970561
- Sponsor's protocol ID
- 2020091
- Acronym
- IDP
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Factors Associated With Postoperative Recurrence of Intraductal Papilloma of the Breast Treated With Ultrasound-guided Vacuum-assisted Rotary Excision
- ClinicalTrials.gov ID
- NCT06970561
- Acronym / sponsor ID
- IDP / 2020091
- Conditions
- Breast Cancer Surgery, Benign Breast Tumors
- Keywords
- intraductal papilloma of the breast, treatment, vacuum-assisted rotational excision therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Wuhan Children's HospitalUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the postoperative recurrence of intraductal papillomas (IDP) treated with ultrasound-guided vacuum-assisted excision (VAE), and to investigate the effect of different lesion characteristics on recurrence.
Detailed description
106 patients with IDP with or without atypical ductal hyperplasia (ADH) treated with ultrasound-guided VAE at Zhongnan Hospital of Wuhan University from January 2020 to August 2024 were selected for the study, and the postoperative conditions of the patients were sorted out and followed up to analyze the characteristics of the lesions and to determine the relevant factors that affected the postoperative recurrence.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recurrent | – | Procedure: enlarged resectionPatients who relapsed after receiving ultrasound-guided vacuum-assisted rotary excision |
| non-recurrent | – | –Patients who did not relapsed after receiving ultrasound-guided vacuum-assisted rotary excision |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- IDP patients who underwent ultrasound-guided VAE treatment from January 2020 to August 2024 in Zhongnan Hospital of Wu han University.
Key inclusion criteria (3 listed)
- IDP was diagnosed pathologically after VAE treatment
- the tumor was a solitary lesion with the margin >1cm from the nipple and the longest diameter of the tumor <3cm
- it was not associated with other breast diseases
Key exclusion criteria (2 listed)
- previous ductal breast surgery
- abnormal coagulation function or taking anticoagulant drugs .recent or current use of hormonal or psychotropic drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enlarged resectionAlso: secondary enlarged resectionpatients underwent secondary enlarged resection within 1 month after the diagnosis of IDP combined with ADH, | Procedure or surgery | recurrent |
Primary outcome
recurrence
Time frame: The cut-off date for follow-up was September 2024
Recurrence was defined as the appearance of a lesion within 2-3 cm of the original surgical area with corresponding clinical manifestations, such as nipple discharge and imaging support, which was later pathologically confirmed as IDP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Surgery and Benign Breast Tumors, run by Wuhan Children's Hospital at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (time frame: The cut-off date for follow-up was September 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2025.