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Predicting and establishing distant metastasis biomarkers for breast cancer as well as relevant treatment research

Predicting and establishing distant metastasis biomarkers for breast cancer as well as relevant treatment research

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036647
Enrollment
Unknown
Registered
2020-08-24
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-09-21

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:Pathological diagnosis
clinical outcome
Index test:ncRNAs Panel

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Female patients >=18 years old and = 1.5 x 10^9/L; Platelet count (PLT) >= 90 x 10^9/L; Hemoglobin (Hb) >= 90 g/L; 2) Blood biochemistry: Total bilirubin (TBIL) <= 1.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 1.5 x ULN; Alkaline phosphatase <= 2.5 x ULN; Urea or urea nitrogen (BUN) and creatinine (Cr)<= 1.5 x ULN; 3) 12-lead ECG: QT interval (QTcF) corrected by Fridericia method < 470 msec. 8. Volunteer to join the study, sign an informed consent form, have good compliance and are willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. The history of any malignant tumor other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma; 2. Suffer from serious concomitant diseases or other comorbid diseases that will interfere with planned treatment, including infectious diseases with active infections (including but not limited to hepatitis B, active hepatitis C, active tuberculosis, active syphilis, etc.), Or the investigator believes that the patient is not suitable for any other situation in this study.

Design outcomes

Primary

MeasureTime frame
Overall Survival;Progression Free Survival;tumor control probability;Adverse Event;SEN, SPE, ACC, AUC of ROC, PPV, NPV;

Countries

China

Contacts

Public ContactLin Fang

Shanghai Tenth People's Hospital

fanglin2017@126.com+86 18917683221

Outcome results

None listed

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