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

NCT06595758 | Completed

• 1 other identifier: Egyptian breast cancer patient
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Cancer

Keywords

Doxorobicin; Pharmacokinetics; SLC22A16; CBR1; SNPs; Toxicity; Neoadjuvant chemotherapy; Pathological complete response; Neutrophil to lymphocyte ratio

Outcome Measures

Primary Outcomes (2)

• Doxorubicin plasma concentrations

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

  baseline

• neutrophil to lymphocyte ratio

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

  baseline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

female Egyptian patients with breast cancer

You may qualify if:

• Females aged ≥ 18 years
• Performance status 0 or 1
• No contraindication to chemotherapy
• Adequate bone marrow
• Adequate hepatic function
• Adequate renal function

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menofia university

Shibīn al Kawm, Egypt

Location

Related Publications (2)

• Lal S, Wong ZW, Jada SR, Xiang X, Chen Shu X, Ang PC, Figg WD, Lee EJ, Chowbay B. Novel SLC22A16 polymorphisms and influence on doxorubicin pharmacokinetics in Asian breast cancer patients. Pharmacogenomics. 2007 Jun;8(6):567-75. doi: 10.2217/14622416.8.6.567.

  PMID: 17559346 BACKGROUND

• Speth PA, van Hoesel QG, Haanen C. Clinical pharmacokinetics of doxorubicin. Clin Pharmacokinet. 1988 Jul;15(1):15-31. doi: 10.2165/00003088-198815010-00002.

  PMID: 3042244 BACKGROUND

Related Links

• Development of a predictive model utilizing the neutrophil to lymphocyte ratio to predict neoadjuvant chemotherapy efficacy in early breast cancer patients

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and plasma samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of clinical pharmacy

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)