A Simplified Approach to Predicting the Malignancy of Breast Lesions: Nomogram in Ultrasonography

NCT06185855 | Unknown

• 1 other identifier: LY2023-210-B
• Study Type: observational
• Target: 550
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to construct and validate a quantitative mammographic model based on breast ultrasound images, incorporating patient characteristics such as age and significant sonographic features. The model is intended for precise discrimination of breast lesions while assessing its diagnostic performance in clinical practice. Our goal is to provide a reliable adjunct tool to enhance the clinical decision-making of healthcare professionals and potentially improve early screening and accurate diagnosis of breast diseases.

Conditions

Breast Cancer Diagnosis; Breast Cancer

Keywords

Breast cancer diagnosis; Mammographic model; Breast disease; Clinical decision-making; Quantitative analysis

Outcome Measures

Primary Outcomes (1)

• Accuracy of the Ultrasonographic Nomogram in Predicting Breast Lesion Malignancy

  The primary outcome measure is the accuracy of the developed nomogram in differentiating between malignant and benign breast lesions. This will be determined by comparing the nomogram's predictions against the actual histopathological findings from breast lesion surgeries. Accuracy will be quantified in terms of sensitivity, specificity, positive predictive value, negative predictive value, and the area under the receiver operating characteristic curve (AUC).

  Retrospective analysis of data collected from January 2020 to June 2023

Study Arms (2)

Malignant

Malignant Breast Lesion Group: This group would include patients diagnosed with breast cancer who have undergone breast lesion surgery and had preoperative ultrasound examinations at the hospital.

Other: Retrospective Ultrasonographic Data Analysis

Benign

Benign Breast Lesion Control Group: This group would consist of patients with benign breast lesions, who also underwent breast lesion surgery and had preoperative ultrasound examinations.

Other: Retrospective Ultrasonographic Data Analysis

Interventions

Retrospective Ultrasonographic Data Analysis OTHER

The intervention involves a detailed retrospective analysis of ultrasonographic data from patients who underwent breast lesion surgery. The study focuses on developing a quantitative nomogram model, which integrates patient age and significant sonographic characteristics of breast lesions. The purpose is to differentiate breast lesions and assess their malignancy in a non-invasive, accurate manner. This analysis uses data collected from January 2020 to June 2023, including clinical and ultrasound examination records from patients who met the inclusion criteria. The intervention does not involve any direct patient interaction or new diagnostic procedures.

Benign; Malignant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients who underwent breast lesion surgery at Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, between January 2020 and June 2023. This population is diverse in terms of age and includes individuals diagnosed with various types of breast lesions, ranging from benign to malignant. All participants had undergone preoperative ultrasound examinations, which are critical for the retrospective analysis in this study.

You may qualify if:

• Patients who underwent breast lesion surgery at Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine during the specified period (January 2020 to June 2023).
• Patients who had a preoperative ultrasound examination of the breast lesion at the same hospital.
• Availability of complete clinical and ultrasonographic data for the patients.
• Histopathological confirmation of breast lesions post-surgery.

You may not qualify if:

• Patients who received neoadjuvant therapy (chemotherapy, targeted therapy, immunotherapy, etc.) prior to surgery.
• Patients diagnosed with metastatic breast malignancy.
• Cases with poor quality or incomplete ultrasound images.
• Patients with a Breast Imaging Reporting and Data System (BI-RADS) category 1 diagnosis.
• Incomplete clinical records or missing critical data relevant to the study.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lixin Jiang

  Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lixin Jiang

CONTACT

+86-18930173496; jinger_28@sina.com

Qian Yu

CONTACT

+86-18217733270; yuqian@renji.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: December 29, 2023
• Study Start: December 30, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share