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

NCT ID: NCT06595758

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-11-01

Brief Summary

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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).

Detailed Description

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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 \[ retrospective study\].

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Naglaa Fathy Mohamed Ebaid

Assistant Lecturer of clinical pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menofia university

Shibīn al Kawm, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 17559346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3042244 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/33446717/

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

Other Identifiers

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Egyptian breast cancer patient

Identifier Type: -

Identifier Source: org_study_id

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