Study of CYP2C19 and ALDH3A1 Polymorphisms in Breast Cancer Patients

NCT04581967 | Unknown FDA Drug

• 1 other identifier: 201819010.4
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.evaluate the frequency or incidence of the genetic polymorphisms of CYP2C19 and ALDH3A1 in breast cancer patients, and
2. 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

Outcome Measures

Primary Outcomes (2)

• The frequency of the genetic polymorphisms of CYP2C19 in breast cancer patients

  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 weeks

• The frequency of the genetic polymorphisms of ALDH3A1 in breast cancer patients

  the blood samples will be DNA extracted by DNA extraction kit then single nucleotide polymorphisms of ALDH3A1 gene will be detected by real time PCR

  Up to 24 weeks

Secondary Outcomes (2)

• Correlation between genetic polymorphisms of CYP2C19 and toxicities from Doxorubicin-Cyclophosphamide regimen therapy

  up to 24 weeks

• Correlation between genetic polymorphisms of ALDH3A1 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: 18 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 patients receiving either adjuvant or neoadjuvant therapy in National Cancer Institute

You may qualify if:

• Confirmed diagnosis of breast cancer.
• Age ranging from 18 to 75 years old female.
• Patients will take Doxorubicin-Cyclophosphamide regimen as chemotherapy treatment.

You may not qualify if:

• Any other malignancy.
• Previous treatment for metastatic disease.
• Pregnancy or breastfeeding female.
• Inadequate bone marrow and cardiac function.
• Serious or uncontrolled medical conditions.

Sponsors & Collaborators

• Damanhour University: lead
• Al-Azhar University: collaborator
• National Cancer Institute, Egypt: collaborator

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

RECRUITING

Related Publications (6)

• Sharma GN, Dave R, Sanadya J, Sharma P, Sharma KK. Various types and management of breast cancer: an overview. J Adv Pharm Technol Res. 2010 Apr;1(2):109-26.

  PMID: 22247839 BACKGROUND

• 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

• Jones SE, Savin MA, Holmes FA, O'Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, Sandbach J, Hyman WJ, Khandelwal P, Negron AG, Richards DA, Anthony SP, Mennel RG, Boehm KA, Meyer WG, Asmar L. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006 Dec 1;24(34):5381-7. doi: 10.1200/JCO.2006.06.5391.

  PMID: 17135639 BACKGROUND

• Montoya JE, Luna HG, Morelos AB, Catedral MM, Lava AL, Amparo JR, Cristal-Luna GR. Association of creatinine clearance with neutropenia in breast cancer patients undergoing chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide (FAC). Med J Malaysia. 2013 Apr;68(2):153-6.

  PMID: 23629563 BACKGROUND

• Bray J, Sludden J, Griffin MJ, Cole M, Verrill M, Jamieson D, Boddy AV. Influence of pharmacogenetics on response and toxicity in breast cancer patients treated with doxorubicin and cyclophosphamide. Br J Cancer. 2010 Mar 16;102(6):1003-9. doi: 10.1038/sj.bjc.6605587. Epub 2010 Feb 23.

  PMID: 20179710 BACKGROUND

• Zhou X, Qiao G, Wang X, Song Q, Morse MA, Hobeika A, Gwin WR, Ren J, Lyerly HK. CYP1A1 genetic polymorphism is a promising predictor to improve chemotherapy effects in patients with metastatic breast cancer treated with docetaxel plus thiotepa vs. docetaxel plus capecitabine. Cancer Chemother Pharmacol. 2018 Feb;81(2):365-372. doi: 10.1007/s00280-017-3500-9. Epub 2017 Dec 14.

  PMID: 29242966 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA extract 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

  STUDY DIRECTOR

• Marwa Nabeel, Ass. Prof

  National Cancer Institute-Cairo University

  STUDY CHAIR

• Amira Bisheer, PhD

  faculty of pharmacy, Damanhour University

  PRINCIPAL INVESTIGATOR

• Esraa Khaled, B. Pharm

  faculty of pharmacy, Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hoda Salem, Ass. Prof

CONTACT

00201000007613; hsalem@ut.edu.sa

Esraa Khaled, B. Pharm

CONTACT

00201009956676; esraakhaled11@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: October 9, 2020
• Study Start: October 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: January 15, 2021
• Last Updated: October 9, 2020

Record last verified: 2020-08

Locations

EG (1)