Clinical trial NCT06979921: PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale BREAST Cancers, PERCEIVE-BREAST
Official title: Breast Cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Retrospective and Prospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Keywords: cancer
liquid biopsy
early detection
cell-free DNA methylation
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Guangzhou Bruning Rock Bioengineering Ltd
First posted: 2025-05-20
Enrollment: 496
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of breast cancer or breast benign disease.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The sensitivity and specificity of cell-free DNA (cfDNA) methylation in the detection of breast cancer.
timeFrame: 48 months
measure: The sensitivity and specificity of circulating tumor DNA (ctDNA) mutations in the detection of breast cancer.
timeFrame: 48 months
measure: The sensitivity and specificity of blood miRNA in the detection of breast cancer.
timeFrame: 48 months
Secondary outcomes:
measure: The sensitivity and specificity of the multi-omics model in the detection of breast cancer.
timeFrame: 48 months
measure: The sensitivity and specificity of various omics-based models for detecting different molecular subtypes of breast cancer.
timeFrame: 48 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Qingdao
country: China
facility: The Affiliated Hospital of Medical College Qingdao University
state: Shandong
Study officials:
References: