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

NCT ID: NCT06979921

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

496 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-10

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Cancer arm

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

Blood test

Intervention Type DEVICE

Blood test

Benign disease arm

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

Blood test

Intervention Type DEVICE

Blood test

Interventions

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Blood test

Blood test

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Bruning Rock Bioengineering Ltd

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Site Status

The Affiliated Hospital of Medical College Qingdao University

Qingdao, Shandong, China

Site Status

Countries

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China

Other Identifiers

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JSSRM-2021013

Identifier Type: -

Identifier Source: org_study_id

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