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

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05733026

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Cardiotoxicity [6 months]
Occurrence of dilated cardiomyopathy

Secondary Outcome Measures

Nephrotoxicity [6 months]
Occurrence of nephrotoxicity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt	11315

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neven Sarhan, Lecturer, Misr International University

ClinicalTrials.gov Identifier:

NCT05733026

Other Study ID Numbers:

BC-Genetics

First Posted:

Feb 17, 2023

Last Update Posted:

Feb 17, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Neven Sarhan, Lecturer, Misr International University

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Feb 17, 2023