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

NCT ID: NCT05733026

Last Updated: 2023-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Breast cancer patients who developed cardiotoxic side effects in response to Doxorubicin treatment

No interventions assigned to this group

2

Breast cancer patients who did not develope cardiotoxic side effects in response to Doxorubicin treatment

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Neven Sarhan

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Neven Sarhan, PhD

Role: CONTACT

+201021944422

Mona Schaalan, PhD

Role: CONTACT

Facility Contacts

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Neven Sarhan, PhD

Role: primary

Other Identifiers

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BC-Genetics

Identifier Type: -

Identifier Source: org_study_id

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