Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Doxorubicin Among Egyptian Breast Cancer Patients

Recent advances in technologies, such as microarray and high-throughput sequencing, represented a deeper understanding of molecular biology, especially noncoding RNA (ncRNA). It was found that there are only <2 % of the total genome sequence as protein-coding genes while at least 98 % of the genome are transcribed into ncRNA. In the past, non-protein-coding RNAs were known as "transcription noise," but now it is obvious that ncRNAs play a crucial regulatory role in cell differentiation and organism growth and metabolism.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Neven Sarhan, PhD; Phone Number: +201021944422; Email: sarhanneven@gmail.com
• Study Contact Backup: Name: Mona Schaalan, PhD; Email: mona.schaalan@miuegypt.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11315
    • Recruiting
    • Ain shams university
    • Contact: Neven Sarhan, PhD; Email: sarhanneven@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Metastatic and localized breast cancer patients treated with Doxorubicin

Description

Inclusion Criteria:

• Metastatic and localized breast cancer patients treated with Doxorubicin among chemotherapeutic protocol.
• Measurable disease.
• Age of 18 years to 80 years.
• The women of childbearing age must use an effective contraception for the duration of the study.

Exclusion Criteria:

• Breast cancer patients who had undergone radiotherapy or chemotherapy.
• Pregnant and lactating females.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to chemotherapeutic agents used.
• Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the inclusion of the patient in the study inappropriate in the opinion of the investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Breast cancer patients who developed cardiotoxic side effects in response to Doxorubicin treatment
2; Breast cancer patients who did not develope cardiotoxic side effects in response to Doxorubicin treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiotoxicity	Occurrence of dilated cardiomyopathy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nephrotoxicity	Occurrence of nephrotoxicity	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): January 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Cardiotoxicity; Gene polymorphism; Doxorubcin
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BC-Genetics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No