Breast CancerNCT04569955
Knowledge and Perception of Clinical Trial Participation in Breast Cancer Patients in Egypt
An observational study of Breast Cancer and Clinical Trials, run by Ain Shams University at 1 site in Egypt.
Trial summary
Clinical trials are essential to translate new therapy concepts or rather any intervention into the medical routine. Beside the well designed trial protocol, the success of clinical trials depends on patient recruitment and participation. Read more about this study
- Who is it for?
- Ages Up to 80 years, women only
- Conditions the study is for
- Breast Cancer, Clinical Trials
- What is being tested?
- Knowledge and perception of clinical trial participation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2020to Dec 2020
- 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 Up to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: -Egyptian female Breast cancer patients
Who may be able to join
- Female breast cancer patients
Who cannot join
- Patients who refuse participation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university, faculty of medicine
Cairo, Select, 1667
Hagar Elghazawy, MD, 01006232406, hagaribrahim1@hotmail.com
About this study
Official title: Knowledge and Perception of Clinical Trial Participation in Breast Cancer Female Patients in Egypt, a Cross Sectional Study
- Clinical trials are essential to translate new therapy concepts or rather any intervention into the medical routine. Beside the well designed trial protocol, the success of clinical trials depends on patient recruitment and participation.
- This study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in Breast cancer female patients in Egypt, as an example to Low/Middle income countries.
- Conditions
- Breast Cancer, Clinical Trials
- Being tested
- Knowledge and perception of clinical trial participation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge and perception of clinical trial participationBehavioural
This study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in Breast cancer female patients in Egypt, as an example to Low/Middle income countries
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of breast cancer patients who accept to participate in clinical trials
Measured: 1 year
Secondary outcomes (1)
The barriers for participation in clinical trials
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start20 Jul 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Elghazawy, Ain Shams University
- Investigators
- Hagar Elghazawy, Principal investigator, Ain shams university, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569955
- Sponsor's protocol ID
- FMASU R61/2020
- Status last verified
- Sep 2020
- First submitted
- 7 Jul 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Perception of Clinical Trial Participation in Breast Cancer Female Patients in Egypt, a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04569955
- Acronym / sponsor ID
- FMASU R61/2020
- Conditions
- Breast Cancer, Clinical Trials
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Sep 2020 (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.
- Clinical trials are essential to translate new therapy concepts or rather any intervention into the medical routine. Beside the well designed trial protocol, the success of clinical trials depends on patient recruitment and participation.
- This study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in Breast cancer female patients in Egypt, as an example to Low/Middle income countries.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- -Egyptian female Breast cancer patients
Key inclusion criteria (1 listed)
- Female breast cancer patients
Key exclusion criteria (1 listed)
- Patients who refuse participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knowledge and perception of clinical trial participationThis study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in Breast cancer female patients in Egypt, as an example to Low/Middle income countries | Behavioural | – |
Primary outcome
The percentage of breast cancer patients who accept to participate in clinical trials
Time frame: 1 year
1 secondary outcome
The barriers for participation in clinical trials
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Hagar Elghazawy principal investigator
Ain shams university, faculty of medicine
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 and Clinical Trials, 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 1 inclusion and 1 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 30 Sep 2020. 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 Hagar Elghazawy, MD (01006232406, dr.hagar.elghazawy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of breast cancer patients who accept to participate in clinical trials (time frame: 1 year). 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 30 Sep 2020.