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Exosomes as potential prognostic and predictive biomarkers to assess the tumor response to neoadjuvant chemotherapy in breast cancer patients

Exosomes as potential prognostic and predictive biomarkers to assess the tumor response to neoadjuvant chemotherapy in breast cancer patients

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026195
Enrollment
Unknown
Registered
2019-09-26
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Gold Standard:1. Pathological diagnosis as the gold standard for breast cancer diagnosis. 2. Chemotherapy response according to RECIST (version 1.1) solid tumor efficacy evaluation criteria.
RNR-Seq&#32
analysis&#32
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analysis.

Sponsors

Medical Research Ethics Committee of Binzhou Medical University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged more than 18 years. 2. Histologically proven invasive carcinoma of the breast and locally advanced stage (tumor size >= 2 cm). 3. Neo-adjuvant chemotherapy with anthracyclines and taxanes. 4. Expected survival >= 6 months. 5. Initial required laboratory values: Absolute neutrophil count >/= 1.5 x 10^9/L Platelet count >= 100,000 x 10^9 /L Creatinine clearance >= 50mL/min (calculated by Cockcroft-Gault method) Liver function tests (AST, ALT, total bilirubin) <= 2.5 x ULN Urine or serum HCG negative (if female of childbearing potential). 6. No prior chemotherapy. 7. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of metastatic disease at diagnosis. 2. Breast Cancer inflammatory. 3. Rare histologic subtypes (non ductal lobular and not). 4. Other cancer (except basal cell skin carcinoma and cancer of the cervix in situ adequately treated and curative) treated in the previous 5 years. 5. Patient pregnant or nursing or of childbearing age without effective contraception. 6. Breast cancer in men. 7. Legal incapacity or limited legal capacity. medical or psychological conditions allowing the subject to complete the study or to sign the consent.

Design outcomes

Primary

MeasureTime frame
exosomes;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactWang Xiaohong

Binzhou Medical University Hospital

wangxiaohong0607@126.com+86 13465058569

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026