Breast CancerNCT03762642
Trends of Mastectomy and Breast-Conserving Surgery in Female Breast Cancer Patients
An observational study of Breast Cancer and Breast Neoplasms, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Breast cancer is the most common cancer in women across the world, accounting for 25.2% of cancer cases among females and 14.7% of cancer-related deaths among females worldwide. The survival rates are markedly lower in the developing countries compared to developed countries, as well as the age at diagnosis. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- What is being tested?
- Mastectomy and Breast-Conserving Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 335 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 17 Jul 2017to 2 Aug 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female breast cancer patients who underwent surgery for breast cancer in King Abdulaziz University hospital between 2009 and June 2017 excluding those who had metastasis or recurrence before the surgery
Who may be able to join
- Female, diagnosed with breast cancer, underwent surgery on the breast tumor in King Abdulaziz University Hospital
Who cannot join
- Patients with metastatic breast cancer or recurrence of the cancer before the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trends of Mastectomy and Breast-Conserving Surgery and Related Factors in Female Breast Cancer Patients Treated at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, 2009-2017
Breast cancer is the most common cancer in women across the world, accounting for 25.2% of cancer cases among females and 14.7% of cancer-related deaths among females worldwide. The survival rates are markedly lower in the developing countries compared to developed countries, as well as the age at diagnosis. Core management of breast cancer includes surgical removal of the tumor either by breast-conserving surgery (BCS) or mastectomy (removal of the whole breast). Choosing between these two procedures may be influenced by factors that have yet to be studied in Saudi Arabia. The investigators aimed to determine the prevalence of BCS and mastectomy and the factors that may influence the choice of procedure. This retrospective study was carried out by reviewing the records of female breast cancer patients who underwent BCS or mastectomy at King Abdulaziz University Hospital between 2009 to June 2017, excluding those with metastasis (distant spread of the cancer) or recurrence. Using frequencies for the rate, and multivariate tests, the investigators analyzed different demographic, clinicopathological, and radiological factors to detect correlations with procedure choice.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- Being tested
- Mastectomy, Breast-Conserving Surgery
- Keywords
- Breast Cancer Surgery, Lumpectomy, Surgery Choice, Procedure Choice, Surgical Outcome
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MastectomyProcedure or surgery
Removal of the whole breast
Breast-Conserving SurgeryProcedure or surgery
Also called Lumpectomy
Removal of the cancerous tissue only
| Study group | Role | What they receive |
|---|---|---|
| Mastectomy | Not described Receives: Procedure: Mastectomy | |
| Breast-Conserving Surgery | Not described Receives: Procedure: Breast-Conserving Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of each of mastectomy and breast-conserving surgery
The percentage of of patients who underwent each surgery
Measured: 2009-2017
Secondary outcomes (10)
The relationship between the choice of procedure and the patients' age (in years)
Statistical analysis using independent sample T-test and binary logistic regression
Measured: 2009-2017
The relationship between the choice of procedure and the use of preoperative chemotherapy (also called "neoadjuvant chemotherapy")
Statistical analysis using Chi-square test and binary logistic regression
Measured: 2009-2017
The relationship between the choice of procedure and the tumor's laterality (right versus left breast cancer)
Statistical analysis using Chi-square test and binary logistic regression
Measured: 2009-2017
The relationship between the choice of procedure and the tumor's focality (whether it is composed of more than one mass)
Statistical analysis using Chi-square test and binary logistic regression
Measured: 2009-2017
The relationship between the choice of procedure and the tumor's centricity (whether it involves more than one quadrant of the breast)
Statistical analysis using Chi-square test and binary logistic regression
Measured: 2009-2017
The relationship between the choice of procedure and the tumor's size (in centimeters)
Statistical analysis using independent sample T-test and binary logistic regression
Measured: 2009-2017
The relationship between the choice of procedure and the tumor's stage (using the 7th "American Joint Committee on Cancer"'s staging guidelines)
Statistical analysis using Chi-square test and binary logistic regression
Measured: 2009-2017
The relationship between the choice of procedure and the tumor's histological grade (using the Nottingham Histologic Score system)
Statistical analysis using Chi-square test and binary logistic regression
Measured: 2009-2017
The relationship between the choice of procedure and the tumor's receptor status (whether it is positive for estrogen, progesterone, and/or human epidermal growth factor receptor 2)
Statistical analysis using Chi-square test and binary logistic regression
Measured: 2009-2017
The relationship between the choice of procedure and having preoperative magnetic resonance imaging of the breast and its findings
Statistical analysis using Chi-square test and binary logistic regression
Measured: 2009-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start17 Jul 2017
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
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.
- 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
- Retrospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zuhoor K. AL-Sharif, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762642
- Sponsor's protocol ID
- 357-71
- Status last verified
- Dec 2018
- First submitted
- 30 Nov 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trends of Mastectomy and Breast-Conserving Surgery and Related Factors in Female Breast Cancer Patients Treated at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, 2009-2017
- ClinicalTrials.gov ID
- NCT03762642
- Acronym / sponsor ID
- 357-71
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- Keywords
- Breast Cancer Surgery, Lumpectomy, Surgery Choice, Procedure Choice, Surgical Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 4 Dec 2018 (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.
Breast cancer is the most common cancer in women across the world, accounting for 25.2% of cancer cases among females and 14.7% of cancer-related deaths among females worldwide. The survival rates are markedly lower in the developing countries compared to developed countries, as well as the age at diagnosis. Core management of breast cancer includes surgical removal of the tumor either by breast-conserving surgery (BCS) or mastectomy (removal of the whole breast). Choosing between these two procedures may be influenced by factors that have yet to be studied in Saudi Arabia. The investigators aimed to determine the prevalence of BCS and mastectomy and the factors that may influence the choice of procedure. This retrospective study was carried out by reviewing the records of female breast cancer patients who underwent BCS or mastectomy at King Abdulaziz University Hospital between 2009 to June 2017, excluding those with metastasis (distant spread of the cancer) or recurrence. Using frequencies for the rate, and multivariate tests, the investigators analyzed different demographic, clinicopathological, and radiological factors to detect correlations with procedure choice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mastectomy | – | Procedure: Mastectomy |
| Breast-Conserving Surgery | – | Procedure: Breast-Conserving Surgery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female breast cancer patients who underwent surgery for breast cancer in King Abdulaziz University hospital between 2009 and June 2017 excluding those who had metastasis or recurrence before the surgery
Key inclusion criteria (1 listed)
- Female, diagnosed with breast cancer, underwent surgery on the breast tumor in King Abdulaziz University Hospital
Key exclusion criteria (1 listed)
- Patients with metastatic breast cancer or recurrence of the cancer before the surgery
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 |
|---|---|---|
| MastectomyRemoval of the whole breast | Procedure or surgery | Mastectomy |
| Breast-Conserving SurgeryAlso: LumpectomyRemoval of the cancerous tissue only | Procedure or surgery | Breast-Conserving Surgery |
Primary outcome
Prevalence of each of mastectomy and breast-conserving surgery
Time frame: 2009-2017
The percentage of of patients who underwent each surgery
10 secondary outcomes
The relationship between the choice of procedure and the patients' age (in years)
Time frame: 2009-2017
The relationship between the choice of procedure and the use of preoperative chemotherapy (also called "neoadjuvant chemotherapy")
Time frame: 2009-2017
The relationship between the choice of procedure and the tumor's laterality (right versus left breast cancer)
Time frame: 2009-2017
The relationship between the choice of procedure and the tumor's focality (whether it is composed of more than one mass)
Time frame: 2009-2017
The relationship between the choice of procedure and the tumor's centricity (whether it involves more than one quadrant of the breast)
Time frame: 2009-2017
The relationship between the choice of procedure and the tumor's size (in centimeters)
Time frame: 2009-2017
The relationship between the choice of procedure and the tumor's stage (using the 7th "American Joint Committee on Cancer"'s staging guidelines)
Time frame: 2009-2017
The relationship between the choice of procedure and the tumor's histological grade (using the Nottingham Histologic Score system)
Time frame: 2009-2017
The relationship between the choice of procedure and the tumor's receptor status (whether it is positive for estrogen, progesterone, and/or human epidermal growth factor receptor 2)
Time frame: 2009-2017
The relationship between the choice of procedure and having preoperative magnetic resonance imaging of the breast and its findings
Time frame: 2009-2017
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 6 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Neoplasms, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 6 Dec 2018. 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 Saudi Arabia. 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?
Prevalence of each of mastectomy and breast-conserving surgery (time frame: 2009-2017). 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 6 Dec 2018.