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Search / Trial NCT06595758

This Study Investigates the Impact of Single Nucleotide Polymorphisms in Genes Involved in the Pharmacokinetics and Toxicity of Doxorubicin (DOX) in Egyptian Female Patients with Breast Cancer. It Also Aims to Explore the Association of Pretreatment Neutrophil to Lymphocyte Ratio to PCR

Launched by MENOUFIA UNIVERSITY · Sep 11, 2024

Trial Information

Current as of June 05, 2025

Completed

Keywords

Doxorobicin Pharmacokinetics Slc22 A16 Cbr1 Sn Ps Toxicity Neoadjuvant Chemotherapy Pathological Complete Response Neutrophil To Lymphocyte Ratio

ClinConnect Summary

Plasma concentrations of doxorubicin will be determined and venous blood samples will be obtained from each patient for SNP genotyping of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients \[prospective study\].

A complete blood count was carried out at baseline for patients receiving neoadjuvant chemotherapy. The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes \[ retrospective study\].

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Females aged ≥ 18 years
  • Performance status 0 or 1
  • No contraindication to chemotherapy
  • Adequate bone marrow
  • Adequate hepatic function
  • Adequate renal function
  • Exclusion Criteria:
  • Poorly controlled diabetes mellitus
  • Ischemic heart disease
  • Uncontrolled hypertension
  • Active infections
  • Baseline ejection fraction \< 50%
  • Performance status ≥ 2
  • Pregnancy Lactation, bilateral breast cancer, male patients, primary surgery, distant metastases, other malignancies, inflammations, hematological disorders, autoimmune diseases, and patients taking non-steroidal anti-inflammatory drugs (NSAIDs), steroidal and antibiotic therapy.

About Menoufia University

Menoufia University is a prominent educational and research institution located in Egypt, dedicated to advancing medical science and improving healthcare outcomes through innovative clinical research. The university's clinical trial sponsorship is characterized by a commitment to ethical standards, rigorous scientific methodology, and collaboration with multidisciplinary teams. By leveraging its academic resources and expertise, Menoufia University aims to contribute to the development of new therapies and interventions, ultimately enhancing patient care and public health within the region and beyond.

Locations

Shibīn Al Kawm, , Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported