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Completed

NCT Number: NCT03080623

Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion

This study proposed to construct an ultrasound-based diagnostic model for Differentiating Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and prospective part, which are designed for model construction and independent validation, respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the efficacy of the model for identifying malignant breast lesion from benign lesion, and finally promote the application of this diagnostic model in more clinics.

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Key information

Conditions

Breast Cancer Female Diagnoses Disease

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female
  • with single breast lesion(maximum diameter>0.8 cm)
  • agree to receive follow-up in six months and take the second breast ultrasound six month after the first breast ultrasound, if a benign diagnosis is achieved at the first ultrasound
  • sign the informed consent

Exclusion criteria

  • lost to follow-up
  • failed to take the second breast ultrasound six month after the first breast ultrasound

Treatment and study plan

Primary outcomes

  1. breast biopsy proved malignant or benign lesion

    Time frame: between breast ultrasound and biopsy(one week)

    for patients regarded as malignant by the breast ultrasound, breast biopsy results are used as reference test, which determines the breast lesion is malignant or benign

  2. two breast ultrasound identified benign lesion

    Time frame: between first detection of breast lesion and the second ultrasound(six month)

    for patients regarded as benign by the breast ultrasound, they will receive a second breast ultrasound after six month(this is regular examination for patients with first detected breast lesion). If the second ultrasound indicates benign, the lesion will be regarded as benign

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2017
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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