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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06979921

Enrollment

496

Registered

2025-05-20

Start date

2021-07-10

Completion date

2026-12-30

Last updated

2025-08-14

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

Conditions

Cancer

Keywords

cancer, liquid biopsy, early detection, cell-free DNA methylation

Brief summary

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.

Interventions

DEVICEBlood test

Blood test

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The sensitivity and specificity of cell-free DNA (cfDNA) methylation in the detection of breast cancer.	48 months
The sensitivity and specificity of circulating tumor DNA (ctDNA) mutations in the detection of breast cancer.	48 months
The sensitivity and specificity of blood miRNA in the detection of breast cancer.	48 months

Secondary

Measure	Time frame
The sensitivity and specificity of the multi-omics model in the detection of breast cancer.	48 months
The sensitivity and specificity of various omics-based models for detecting different molecular subtypes of breast cancer.	48 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026