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A Prospective Diagnostic Trial of Contrast-enhanced Ultrasound for evaluating the post-operative upgrade risk of ductal carcinoma in situ (DCIS).

A Prospective Diagnostic Trial of Contrast-enhanced Ultrasound for evaluating the post-operative upgrade risk of ductal carcinoma in situ (DCIS).

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073775
Enrollment
Unknown
Registered
2023-07-20
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Index test:Contrast-enhanced ultrasound parameters related to DCIS postoperative upgrade

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with breast carcinoma in situ (DCIS) confirmed by preoperative puncture biopsy; 2. Patients who want to undergo total mastectomy or modified radical mastectomy in our hospital; 3. Patients with complete clinical data; 4. Patients with good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients who had been diagnosed with mi-DCIS or DCIS combined with IDC by preoperative biopsy pathology; 2. Patients who received radiotherapy, chemotherapy, endocrine therapy, targeted therapy and other anti-tumor therapy before surgery; 3. Patients with serious heart, lung or other severe diseases; 4. Patients who is pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Contrast-enhanced ultrasound parameters related to DCIS postoperative upgrade;Area under receiver operating characteristic curve;

Secondary

MeasureTime frame
sensitivity;specificity;accuracy;positive predictive value;

Countries

China

Contacts

Public ContactPeng Zhou

Shenzhen Second People's Hospital

zpdahai@163.com+86 136 8955 2105

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026