Actively Recruiting
Molecular Subtyping of Breast Cancer-derived Small Extracellular Vesicles (sEVs) to Predict Therapeutic Efficacy
Led by Fudan University · Updated on 2026-05-08
1500
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to learn if a new diagnostic test using specific labels for breast cancer sEVs on a microchip can accurately diagnose the molecular subtypes in patients with breast cancer. The main questions it aims to answer are: * What is the sensitivity of this new sEVs-based panel for diagnosing breast cancer molecular subtypes? * What is the specificity of this new sEVs-based panel for diagnosing breast cancer molecular subtypes? Researchers will compare the results from the new sEVs panel to the results from the standard pathological diagnosis to see if the new panel is accurate and reliable. Participants will be asked to: * Provide blood samples and tissue samples. * Allow researchers to access their clinical data, such as their diagnosis, treatment information, and outcomes.
CONDITIONS
Official Title
Molecular Subtyping of Breast Cancer-derived Small Extracellular Vesicles (sEVs) to Predict Therapeutic Efficacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years (inclusive)
- ECOG performance status 0-1
- Life expectancy of 3 months or more
- Diagnosis of unresectable or metastatic breast cancer
- Undergoing or planning core needle biopsy of recurrent/metastatic lesions before starting new treatment, with fresh tumor tissue and blood samples provided
- At least one measurable lesion or bone-only metastases according to RECIST v1.1 criteria
- Adequate bone marrow reserve: Platelet count ≥90 x 10⁹/L, absolute neutrophil count ≥1.5 x 10⁹/L, hemoglobin ≥9 g/dL
- Adequate coagulation function: INR ≤1.5, APTT ≤1.5 times upper limit of normal
- Basically normal liver function: total bilirubin ≤1.5 times upper limit of normal (bilirubin ≤3 times ULN allowed for Gilbert's syndrome), AST and ALT ≤2.5 times ULN (≤5 times ULN if liver metastases present)
- Adequate renal function: serum creatinine ≤1.5 times ULN or creatinine clearance ≥50 mL/min
- Adequate cardiac function: left ventricular ejection fraction ≥50%, QTcF ≤470 ms for females and ≤450 ms for males
- Ability to communicate effectively and comply with study requirements
You will not qualify if you...
- Receipt of radiotherapy, chemotherapy, traditional Chinese medicine with anti-tumor effects, or local therapy (excluding biopsy or ablation) within 2 weeks before enrollment
- Unresolved adverse reactions from prior anti-tumor treatments worse than Grade 1 per CTCAE v5.0 (except alopecia, long-term radiotherapy toxicities, or other Grade ≤2 toxicities deemed safe)
- Other cancers within the past 5 years except cured cervical carcinoma in situ or certain skin cancers
- Uncontrolled or serious medical conditions including active infections needing antibiotics
- History of serious heart or brain blood vessel diseases, such as severe arrhythmias, advanced heart failure, recent heart attack, stroke, uncontrolled high blood pressure, or conditions increasing risk of irregular heart rhythms
- History of immunodeficiency or organ/bone marrow transplantation
- HIV infection or active hepatitis B or C infection (with some exceptions for controlled cases)
- Females of childbearing potential who are pregnant or breastfeeding
- Psychiatric illness that may affect study participation
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
X
Xiahong Wang
CONTACT
T
Ting Li
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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