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Study on the best index and the treatment window for monitoring the blood drug concentration of docetaxel and the effect of gene polymorphism on the blood drug concentration of docetaxel

Study on the best index and the treatment window for monitoring the blood drug concentration of docetaxel and the effect of gene polymorphism on the blood drug concentration of docetaxel

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026440
Enrollment
Unknown
Registered
2019-10-10
Start date
2019-11-01
Completion date
Unknown
Last updated
2020-01-20

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

Conditions

Breast Cancer

Interventions

Experimental group:Docetaxel

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically diagnosed malignant tumors and patients who were assessed by the attending physician with docetaxel-containing chemotherapy regimen; 2. Aged not less than 20 years, not more than 80 years 3. Not less than 3 weeks from the last chemotherapy; 4. Adequate renal function (creatinine = 2.0 *10^9/L), white blood cells (>= 4.0 *10^9/L), platelets (>= 100 *10^9/L); 5. Adequate physical condition (PS score 0-2), and the expected survival time are not less than 3 months.

Exclusion criteria

Exclusion criteria: 1. Aged above 80 years; 2. Other malignant tumors; 3. Pregnancy, or lactation, or mental disorders requiring intervention; 4. Severe heart disease, or uncontrollable infections; 5. A history of radiotherapy within four weeks; 6. Uncontrollable hypertension, diabetes; 7. And local or systemic inflammation.

Design outcomes

Primary

MeasureTime frame
The peak concentration;Steady-state concentration;The type of CYP3A5* 3, CYP1B1* 3, ABCB1 1236C > T, ABCB1 2677G > T/A, ABCB1 3435C > T genes;

Countries

China

Contacts

Public ContactGuan Yuyao

Shandong Provincial Third Hospital

guanxiaoyao0815@163.com+86 15275188539

Outcome results

None listed

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