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Completed

NCT Number: 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

This study aims to investigate the effect of single nucleotide polymorphisms (SNPs) of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients.

It also aims to explore the association of pretreatment neutrophil to lymphocyte ratio (NLR) with pathological complete response (pCR).

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Menofia university

Shibīn al Kawm, Egypt

About this study

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].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Doxorubicin plasma concentrations

    Time frame: baseline

    Plasma concentrations of doxorubicin will be determined using a suitable analytical method.

  2. neutrophil to lymphocyte ratio

    Time frame: baseline

    The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Effects of Pharmacogenetics on Pharmacokinetics and Toxicity of Doxorubicin in Egyptian Breast Cancer Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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