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

Nanjing Medical University

Status: Active, not recruiting

Conditions: Cancer

Treatments: Device: Blood test

Study type: Observational

Funder types: Other

Identifiers

NCT06979921

JSSRM-2021013

Details and patient eligibility

About

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.

Enrollment: 496 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

496 participants in 2 patient groups

Cancer arm

Description:

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

Treatment:

Device: Blood test

Benign disease arm

Description:

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

Treatment:

Device: Blood test