A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis

NCT04429269 | Unknown

• 1 other identifier: PUMCH-MUSD
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

Improving the early diagnosis of breast cancer can reduce mortality. With mammography as the main tool for screening early breast cancer, the characteristics of dense breast and young onset of disease in Chinese women lowers the efficiency. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.

Conditions

Breast Cancer Diagnosis; Breast Cancer Screening

Keywords

Mammography; ultrasound; breast cancer screening; early diagnosis

Outcome Measures

Primary Outcomes (1)

• screening yield

  The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods.

  3 years

Secondary Outcomes (1)

• cost-effectiveness

  3 years

Study Arms (1)

mammography and ultrasound

mammography and ultrasound screening

Diagnostic Test: mammography and ultrasound screening

Interventions

mammography and ultrasound screening DIAGNOSTIC_TEST

Patients screened by both mammography and ultrasound.

mammography and ultrasound

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese female subjects aged 35-70 years who were asymptomatic and able to undergo ultrasound and X-rays

You may qualify if:

• Informed consent, subjects 35-70 years old, asymptomatic, able to undergo ultrasound and x-ray

You may not qualify if:

• Localized breast erythema and ulceration, pregnancy, lactation, after previous breast implantation, already pathologically definite breast cancer patients

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (2)

• Wang Y, Li Y, Qu Y, Zhou Y, Sun Q, Shen S. Clinical and imaging characteristics of intraductal papillary neoplasms of the breast: a prospective trial. Discov Oncol. 2024 Dec 23;15(1):831. doi: 10.1007/s12672-024-01681-y.

  PMID: 39715848 DERIVED

• Wang Y, Li Y, Song Y, Chen C, Wang Z, Li L, Liu M, Liu G, Xu Y, Zhou Y, Sun Q, Shen S. Comparison of ultrasound and mammography for early diagnosis of breast cancer among Chinese women with suspected breast lesions: A prospective trial. Thorac Cancer. 2022 Nov;13(22):3145-3151. doi: 10.1111/1759-7714.14666. Epub 2022 Sep 30.

  PMID: 36177910 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy or specimen from volunteers or donors are planned to be collected

MeSH Terms

Conditions

Breast Neoplasms; Disease

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Songjie Shen, MD

  Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and PUMC, BJ, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Songjie Shen, MD

CONTACT

(010) 6915 8721; shensj@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: June 12, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)