Breast NeoplasmNCT05604677
Factor Influencing Breast Surgery Type Decision-Making
An observational study of Breast Neoplasm, run by Etienne El Helou at 1 site in Lebanon.
Trial summary
The aim of this observational study is to determine the factors influencing the decision-making process for breast surgery type, in Lebanese women likely to face breast cancer. The main questions it aims to answer are the presence or not of a correlation between the type of choice and the following data: Demographic… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Breast Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 380 participants
- Where
- 1 siteLebanon
- Study dates
- 15 Jun 2022to 19 Aug 2022
- How long will I take part?
- 1 Day
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: Lebanese Females
Who may be able to join
- Lebanese Females
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Influencing the Decision-making Process for Breast Surgery in Women Likely to Face Breast Cancer.
The aim of this observational study is to determine the factors influencing the decision-making process for breast surgery type, in Lebanese women likely to face breast cancer.
The main questions it aims to answer are the presence or not of a correlation between the type of choice and the following data:
- Demographic
- Health Status
- Several factors that may influence the decision
Participants will complete a well-structured and organized online survey
- Conditions
- Breast Neoplasm
- Being tested
- Breast Surgery
- Keywords
- Breast Cancer, Mastectomy, Breast Conserving Surgery, Lebanese Population, Surgical Choice, Oncoplastic Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast SurgeryProcedure or surgery
Breast-conserving Surgery or modified radical mastectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Influencing Factors
Factors influencing breast surgery type decision making process
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start15 Jun 2022
- Primary completion31 Jul 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- 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
- 380 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Etienne El Helou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Etienne El Helou, Dr Etienne El Helou
- Investigators
- Etienne El-Helou, MD, Principal investigator, Dr Etienne El Helou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604677
- Sponsor's protocol ID
- HelouEl
- Status last verified
- Nov 2022
- First submitted
- 30 Oct 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Decision-making Process for Breast Surgery in Women Likely to Face Breast Cancer.
- ClinicalTrials.gov ID
- NCT05604677
- Acronym / sponsor ID
- HelouEl
- Conditions
- Breast Neoplasm
- Keywords
- Breast Cancer, Mastectomy, Breast Conserving Surgery, Lebanese Population, Surgical Choice, Oncoplastic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Etienne El HelouUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 3 Nov 2022 (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.
The aim of this observational study is to determine the factors influencing the decision-making process for breast surgery type, in Lebanese women likely to face breast cancer.
The main questions it aims to answer are the presence or not of a correlation between the type of choice and the following data:
- Demographic
- Health Status
- Several factors that may influence the decision
Participants will complete a well-structured and organized online survey
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Lebanese Females
Key inclusion criteria (1 listed)
- Lebanese Females
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Breast SurgeryBreast-conserving Surgery or modified radical mastectomy | Procedure or surgery | – |
Primary outcome
Influencing Factors
Time frame: 2 months
Factors influencing breast surgery type decision making process
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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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.
Etienne El-Helou, MD principal investigator
Dr Etienne El Helou
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 Neoplasm, run by Etienne El Helou at 1 site in Lebanon.
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: finished, as of the sponsor's last update on 7 Nov 2022. 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 Lebanon. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influencing Factors (time frame: 2 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 7 Nov 2022.