NCT05733026

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

2.4 years

First QC Date

January 27, 2023

Last Update Submit

February 8, 2023

Conditions

Keywords

DoxorubcinBreast cancerCardiotoxicityGene polymorphism

Outcome Measures

Primary Outcomes (1)

  • Cardiotoxicity

    Occurrence of dilated cardiomyopathy

    6 months

Secondary Outcomes (1)

  • Nephrotoxicity

    6 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Metastatic and localized breast cancer patients treated with Doxorubicin

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11315, Egypt

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsCardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Central Study Contacts

Neven Sarhan, PhD

CONTACT

Mona Schaalan, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 17, 2023

Study Start

August 1, 2020

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations