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NCT Number: NCT06979921

PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale BREAST Cancers, PERCEIVE-BREAST

This study is a retrospective and prospective study aimed to develop and validate the performance of multi-omics assays for early detection of female breast cancer. The study will enroll approximately 496 participants including participants with breast cancers and participants with breast benign diseases.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Jiangsu Provincial People's Hospital, Nanjing, Jiangsu, 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

for All Participants:

  • Able to provide a written informed consent.
  • Female, at least 18 years old.

Additional Inclusion Criteria for Breast Cancer Participants:

  • Pathologically confirmed breast cancer diagnosis or highly suspicious for breast cancer within 42 days prior to blood draw.
  • No prior cancer treatment before the blood draw.

Additional Inclusion Criteria for Breast Benign Disease Participants:

  • Pathologically confirmed breast cancer diagnosis or highly suspicious of breast benign diseases within 90 days prior to blood draw.
  • No prior radical treatment before the blood draw.

Exclusion criteria

for All Participants:

  • During pregnancy or lactation.
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
  • Recipient of blood transfusion within 7 days prior to blood draw.
  • Recipient of anti-tumor drugs to treat non-cancer diseases prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen).

Additional Exclusion Criteria for Breast Cancer Participants:

  • Multiple primary tumors.

Treatment and study plan

Blood test

Device

Blood test

Primary outcomes

  1. The sensitivity and specificity of cell-free DNA (cfDNA) methylation in the detection of breast cancer.

    Time frame: 48 months

  2. The sensitivity and specificity of circulating tumor DNA (ctDNA) mutations in the detection of breast cancer.

    Time frame: 48 months

  3. The sensitivity and specificity of blood miRNA in the detection of breast cancer.

    Time frame: 48 months

Secondary outcomes

  1. The sensitivity and specificity of the multi-omics model in the detection of breast cancer.

    Time frame: 48 months

  2. The sensitivity and specificity of various omics-based models for detecting different molecular subtypes of breast cancer.

    Time frame: 48 months

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Guangzhou Burning Rock Bioengineering Ltd.

Registry information

Official study title

Breast Cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Retrospective and Prospective Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
May 20, 2025
Registry last updated
Aug 14, 2025

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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