Breast CancerNCT05733026
Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Doxorubicin Among Egyptian Breast Cancer Patients
An observational study of Breast Cancer, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic and localized breast cancer patients treated with Doxorubicin
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mona Schaalan, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11315
Neven Sarhan, PhD, sarhanneven@gmail.com
About this study
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.
- Conditions
- Breast Cancer
- Keywords
- Doxorubcin, Breast cancer, Cardiotoxicity, Gene polymorphism
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Cardiotoxicity
Occurrence of dilated cardiomyopathy
Measured: 6 months
Secondary outcomes (1)
Nephrotoxicity
Occurrence of nephrotoxicity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Aug 2020
- Primary completion1 Jan 2023
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neven Sarhan, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733026
- Sponsor's protocol ID
- BC-Genetics
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Doxorubicin Among Egyptian Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05733026
- Acronym / sponsor ID
- BC-Genetics
- Conditions
- Breast Cancer
- Keywords
- Doxorubcin, Breast cancer, Cardiotoxicity, Gene polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic and localized breast cancer patients treated with Doxorubicin
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiotoxicity
Time frame: 6 months
Occurrence of dilated cardiomyopathy
1 secondary outcome
Nephrotoxicity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Schaalan, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neven Sarhan, PhD (+201021944422, sarhanneven@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiotoxicity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.