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Genetic Study of CYP2D6 Enzyme and Therapeutic Drug Monitoring of Tamoxifen

NCT03582865 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-07-08

No results posted yet for this study

Summary

Aim of work:

1. To estimate the frequency of Cyp2D6\*1 and \*4 alleles in Egyptian patients maintained on tamoxifen (20 mg/day) for management of ER +ve breast cancer.
2. To measure levels of tamoxifen, 4-hydroxy tamoxifen, N-desmethyl-tamoxifen and 4- hydroxyl-N-desmethyl-tamoxifen (endoxifen) in the serum of these patients.
3. To correlate between the levels of tamoxifen/active metabolite enoxifen ratio and CYP2D6\*1,\*4 genotyping.
4. To investigate which is more valuable investigatory tool for prediction of the clinical outcome (response and/or toxicity) in these patients; either the measurements related to pharmacokinetics: tamoxifen/endoxifen levels or the pharmacogenetic analysis of CYP2D6 \*1,\*4.

Conditions

Interventions

DRUG

Tamoxifen 20 mg

Tamoxifen 20 mg is a selective estrogen receptor modulator

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Amira Taha · Assiut University

  • Ehab Eldesoky · Assiut University

  • Mohammad Hareedy · Assiut University

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-09-30
Completion
2020-12-31

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Entities

Diseases

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 NCT03582865 on ClinicalTrials.gov