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Study of CYP2C19 and ALDH3A1 Polymorphisms in Breast Cancer Patients

NCT04581967 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-10-09

No results posted yet for this study

Summary

Genetic polymorphisms of metabolic enzymes may influence the metabolism of Doxorubicin-Cyclophosphamide regimen in breast cancer patients.

the investigators want to

1. evaluate the frequency or incidence of the genetic polymorphisms of CYP2C19 and ALDH3A1 in breast cancer patients, and
2. analyze the association between the genetic polymorphisms of CYP2C19 and ALDH3A1 and toxicities in breast cancer patients treated by Doxorubicin-Cyclophosphamide regimen therapy.

Conditions

  • Breast Cancer Patients

Interventions

GENETIC

polymorphism analysis

* DNA will be purified from whole blood samples by commercial DNA isolation kits. * Genotyping and genetic polymorphism detection for some metabolic enzymes genes will be performed by real time PCR.

DRUG

Doxorubicin-Cyclophosphamide regimen

Treatment with a combination of Doxorubicin and Cyclophosphamide, This regimen comprises 60 mg/m² Doxorubicin and 600 mg/m² Cyclophosphamide administered intravenously on day 1 of each 21-day cycle, and repeated for a total of four cycles.

Sponsors & Collaborators

  • Al-Azhar University

    collaborator OTHER

  • National Cancer Institute, Egypt

    collaborator OTHER

  • Damanhour University

    lead OTHER

Principal Investigators

  • Hoda Salem, Ass. Prof · faculty of pharmacy, Al-Azhar university

  • Marwa Nabeel, Ass. Prof · National Cancer Institute-Cairo University

  • Amira Bisheer, PhD · faculty of pharmacy, Damanhour University

  • Esraa Khaled, B. Pharm · faculty of pharmacy, Al-Azhar University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2020-12-15
Completion
2021-01-15
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04581967 on ClinicalTrials.gov