Study of ABCB1,SLC22A16 Drug Transporter Genes and Doxorubicin and Cyclophosphamide Toxicity in Brest Cancer Patient

NCT04654195 | Unknown FDA Drug

• 1 other identifier: 0000012
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

polymorphisms of drug transporter genes may influence of Doxorubicin-Cyclophosphamide toxicity in breast cancer patients. the investigators want to evaluate the association between associations between genetic polymorphisms of ABCB1,SLC22A16 Genes and Toxicity of Doxorubicin and Cyclophosphamide Chemotherapy in Breast Cancer Patients treated by Doxorubicin-Cyclophosphamide regimen therapy

Conditions

Breast Cancer Patients

Outcome Measures

Primary Outcomes (2)

• .1-The frequency of the genetic polymorphisms of ABCB1 in breast cancer patien

  the blood samples will be DNA extracted using DNA extraction kit then single nucleotide polymorphisms of CYP2C19 gene will be detected by real time PCR

  up to 24 week

• The frequency of the genetic polymorphisms of SLC22A16 in breast cancer patients

  the blood samples will be DNA extracted by DNA extraction kit then single nucleotide polymorphisms of SL22A16 gene will be detected by real time PCR

  up to 24 week

Secondary Outcomes (2)

• Correlation between genetic polymorphisms of ABCB1 and toxicities from Doxorubicin-Cyclophosphamide regimen therapy

  up to 24 week

• Correlation between genetic polymorphisms of SLC22A16 and toxicities from Doxorubicin-Cyclophosphamide regimen therapy

  up to 24 weeks

Interventions

polymorphism analysis GENETIC

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.

Also known as: single nucleotide polymorphism

Doxorubicin-Cyclophosphamide regimen DRUG

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.

Also known as: chemotherapy treatment

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all breast cancer females reciving (Ac regimen) at El-hosien University Hospital

You may qualify if:

• women who has confirmed diagnosis of breast cancer.
• patient who will be treated with cyclophosphamide and doxorubicin(AC) regimen only .
• patient take drug regimen for first time.

You may not qualify if:

• \- 1. Patients with metastatic disease and with other previous tumors were excluded from this study 2. Pregnant or nursing female. 3. The patients who were diagnosed with cardiovascular disease or with low left ventricular ejection fraction.
• patients who had benign breast cancers, or had no clinical pathological information

Sponsors & Collaborators

• Damanhour University: lead
• Al-Azhar University: collaborator

Study Sites (1)

Elhussien University Hospital

Cairo, 11651, Egypt

RECRUITING

Related Publications (4)

• Tecza K, Pamula-Pilat J, Lanuszewska J, Butkiewicz D, Grzybowska E. Pharmacogenetics of toxicity of 5-fluorouracil, doxorubicin and cyclophosphamide chemotherapy in breast cancer patients. Oncotarget. 2018 Jan 10;9(10):9114-9136. doi: 10.18632/oncotarget.24148. eCollection 2018 Feb 6.

  PMID: 29507678 BACKGROUND

• Ludovini V, Antognelli C, Rulli A, Foglietta J, Pistola L, Eliana R, Floriani I, Nocentini G, Tofanetti FR, Piattoni S, Minenza E, Talesa VN, Sidoni A, Tonato M, Crino L, Gori S. Influence of chemotherapeutic drug-related gene polymorphisms on toxicity and survival of early breast cancer patients receiving adjuvant chemotherapy. BMC Cancer. 2017 Jul 26;17(1):502. doi: 10.1186/s12885-017-3483-2.

  PMID: 28747156 BACKGROUND

• 3-U.S. department of health and human services(2017): Common Terminology Criteria for Adverse Events (CTCAE),National Cancer Institute ,2017,pp(4-6 ) ,pp(24-44).

  BACKGROUND

• Islam MS, Islam MS, Parvin S, Ahmed MU, Bin Sayeed MS, Uddin MM, Hussain SM, Hasnat A. Effect of GSTP1 and ABCC4 gene polymorphisms on response and toxicity of cyclophosphamide-epirubicin-5-fluorouracil-based chemotherapy in Bangladeshi breast cancer patients. Tumour Biol. 2015 Jul;36(7):5451-7. doi: 10.1007/s13277-015-3211-y. Epub 2015 Feb 13.

  PMID: 25677905 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted by extraction kits from whole blood

MeSH Terms

Interventions

Amplified Fragment Length Polymorphism Analysis; Polymorphism, Single Nucleotide; Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

DNA Fingerprinting; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Polymorphism, Genetic; Genetic Variation; Genetic Phenomena; Combined Modality Therapy; Therapeutics

Study Officials

• Hoda salem, Ass.prof

  Faculty of pharmacy Al-Azhar University for Girls

  STUDY DIRECTOR

• Wael helmy, Ass.prof

  Faculty of medicine Al-Azhar University for Boys

  PRINCIPAL INVESTIGATOR

• Amira bisheer, PhD

  faculty of pharmacy ,Damanhour University

  PRINCIPAL INVESTIGATOR

• sanaa mohsen, B.pharm

  faculty of pharmacy,Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hoda salem, Ass.prof

CONTACT

002010000007613; hsalem@ut.edu.sa

Sanaa mohsen, B.pharm

CONTACT

00201117480060; sanaamohsen9087@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: December 4, 2020
• Study Start: December 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: December 4, 2020

Record last verified: 2020-07

Locations

EG (1)