CancerNCT06979921
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale BREAST Cancers, PERCEIVE-BREAST
An observational study of Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Blood test
- Type of treatment
- Medical device
- How many people
- 496 participants
- Where
- 2 sitesChina
- Study dates
- 10 Jul 2021to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
China2 sites
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
The Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong, 266100
About this study
Official title: Breast Cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Retrospective and Prospective Study
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
- Being tested
- Blood test
- Keywords
- cancer, liquid biopsy, early detection, cell-free DNA methylation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDevice
Blood test
| Study group | Role | What they receive |
|---|---|---|
| Cancer arm | Baseline blood samples will be collected from participants with new diagnosis breast cancer. Receives: Device: Blood test | |
| Benign disease arm | Baseline blood samples will be collected from participants with new diagnosis breast benign disease. Receives: Device: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of cell-free DNA (cfDNA) methylation in the detection of breast cancer.
Measured: 48 months
The sensitivity and specificity of circulating tumor DNA (ctDNA) mutations in the detection of breast cancer.
Measured: 48 months
The sensitivity and specificity of blood miRNA in the detection of breast cancer.
Measured: 48 months
Secondary outcomes (2)
The sensitivity and specificity of the multi-omics model in the detection of breast cancer.
Measured: 48 months
The sensitivity and specificity of various omics-based models for detecting different molecular subtypes of breast cancer.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start10 Jul 2021
- Primary completion31 May 2023
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Bioengineering Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979921
- Sponsor's protocol ID
- JSSRM-2021013
- Status last verified
- Apr 2025
- First submitted
- 29 May 2022
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Retrospective and Prospective Study
- ClinicalTrials.gov ID
- NCT06979921
- Acronym / sponsor ID
- JSSRM-2021013
- Conditions
- Cancer
- Keywords
- cancer, liquid biopsy, early detection, cell-free DNA methylation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 496 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Bioengineering Ltd.
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer arm | – | Device: Blood testBaseline blood samples will be collected from participants with new diagnosis breast cancer. |
| Benign disease arm | – | Device: Blood testBaseline blood samples will be collected from participants with new diagnosis breast benign disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testBlood test | Device | Benign disease arm, Cancer arm |
Primary outcome
The sensitivity and specificity of cell-free DNA (cfDNA) methylation in the detection of breast cancer.
Time frame: 48 months
The sensitivity and specificity of circulating tumor DNA (ctDNA) mutations in the detection of breast cancer.
Time frame: 48 months
The sensitivity and specificity of blood miRNA in the detection of breast cancer.
Time frame: 48 months
2 secondary outcomes
The sensitivity and specificity of the multi-omics model in the detection of breast cancer.
Time frame: 48 months
The sensitivity and specificity of various omics-based models for detecting different molecular subtypes of breast cancer.
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of cell-free DNA (cfDNA) methylation in the detection of breast cancer. (time frame: 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.