Clinical trial · Observational
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale BREAST Cancers, PERCEIVE-BREAST
Breast Cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Retrospective and Prospective Study
NCT06979921CI-TRIAL-00093598active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cancer arm
- description
- Baseline blood samples will be collected from participants with new diagnosis breast cancer.
- interventionNames
- Device: Blood test
- label
- Benign disease arm
- description
- Baseline blood samples will be collected from participants with new diagnosis breast benign disease.
- interventionNames
- Device: Blood test
Primary outcomes (3)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.