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

NCT06979921 | Active Not Recruiting

• 1 other identifier: JSSRM-2021013
• Study Type: observational
• Target: 496
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (2)

Cancer arm

Baseline blood samples will be collected from participants with new diagnosis breast cancer.

Device: Blood test

Benign disease arm

Baseline blood samples will be collected from participants with new diagnosis breast benign disease.

Device: Blood test

Interventions

Blood test DEVICE

Blood test

Benign disease arm; Cancer arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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).
• Multiple primary tumors.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Guangzhou Bruning Rock Bioengineering Ltd: collaborator

Study Sites (2)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Location

The Affiliated Hospital of Medical College Qingdao University

Qingdao, Shandong, 266100, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: May 20, 2025
• Study Start: July 10, 2021
• Primary Completion: May 31, 2023
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-04

Locations

CN (2)