Non Metastatic Breast CancerNCT02901223
The Impact of Oncoplastic Breast Surgery on the Oncological Safety and Patient Satisfaction
A study testing Standard quadrantectomy and oncoplastic breast surgery in people with Non Metastatic Breast Cancer, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to asses the oncological safety of oncoplastic breast surgery, its impact on patient satisfaction and is it worthy for general breast surgeon to learn different oncoplastic techniques. Read more about this study
- Who is it for?
- Ages Up to 60 years, women only
- Conditions the study is for
- Non Metastatic Breast Cancer
- What is being tested?
- Standard quadrantectomy and oncoplastic breast surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2012to May 2016
- Phase
- Interventional
- 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 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Stage 1, 2 breast cancer
- Non metastatic breast caner
- Singing informed consent
Who cannot join
- Metastatic breast cancer
- Stage 3, 4 breast cancer
- Inflammatory breast cancer
- Multicentric/multifocal disease
- Ductal carcinoma in situ
- Patients older than 60 years
Show all 9Show fewer
- History of breast surgery in oncoplastic group
- Co-morbidity in oncoplastic group
- Patients more than 60 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oncoplastic Breast Surgery Allow Tumor Resection With More Oncological Safety Than Standard Quadrantectomy With Nice Cosmetic Results and Better Quality of Life
The aim of this study is to asses the oncological safety of oncoplastic breast surgery, its impact on patient satisfaction and is it worthy for general breast surgeon to learn different oncoplastic techniques.
Read the detailed description
This non randomized prospective trial was conducted on 70 female patients presented to our tertiary referral breast unit -Ain Shams University hospitals with non metastatic breast cancer during the period from September 2012 to September 2013. All of them signed an informed consent to share in this study that was approved in the ethical committee held on April 2012 - Ain Shams University. Our patients were divided into 2 equal groups: group A (35patients) who underwent standard quadrantectomy, group B (35 patients) who underwent oncoplastic surgery. In group A all quadrantectomies were done by general breast surgeons while in group B the oncoplastic procedures were done by well trained oncoplastic breast surgeons not assisted by plastic surgeons. The following data were reported in all cases including: age, family history, tumor size, volume and weight of the specimen, location of tumor, margin length, (primary tumor, regional nodes, metastasis) staging, molecular subtype and patient satisfaction.
- Conditions
- Non Metastatic Breast Cancer
- Being tested
- Standard quadrantectomy, oncoplastic breast surgery
- Keywords
- Oncoplastic breast surgery, oncological safety, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard quadrantectomyProcedure or surgery
standard conservative surgery with no use of any plastic techniques
oncoplastic breast surgeryProcedure or surgery
Integration of plastic techniques with oncological procedures
| Study group | Role | What they receive |
|---|---|---|
| Quadrantectomy group | Active comparator | 35 female patients with non metastatic breast cancer who had standard conservative breast surgery by general breast surgeons. Receives: Procedure: Standard quadrantectomy |
| oncoplastic group | Active comparator | 35 female patients with non metastatic breast cancer who had oncoplastic techniques for tumor resection by well trained oncoplastic breast surgeons. Receives: Procedure: oncoplastic breast surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Margins in all specimens measured in millimeters.
Measured: two years.
Patient satisfaction assessed using questionnaire.
Measured: Two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Metastatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mohamed Abdel-samii, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901223
- Sponsor's protocol ID
- IRB0006379
- Status last verified
- Sep 2016
- First submitted
- 31 Aug 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncoplastic Breast Surgery Allow Tumor Resection With More Oncological Safety Than Standard Quadrantectomy With Nice Cosmetic Results and Better Quality of Life
- ClinicalTrials.gov ID
- NCT02901223
- Acronym / sponsor ID
- IRB0006379
- Conditions
- Non Metastatic Breast Cancer
- Keywords
- Oncoplastic breast surgery, oncological safety, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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 study is to asses the oncological safety of oncoplastic breast surgery, its impact on patient satisfaction and is it worthy for general breast surgeon to learn different oncoplastic techniques.
Detailed description
This non randomized prospective trial was conducted on 70 female patients presented to our tertiary referral breast unit -Ain Shams University hospitals with non metastatic breast cancer during the period from September 2012 to September 2013. All of them signed an informed consent to share in this study that was approved in the ethical committee held on April 2012 - Ain Shams University. Our patients were divided into 2 equal groups: group A (35patients) who underwent standard quadrantectomy, group B (35 patients) who underwent oncoplastic surgery. In group A all quadrantectomies were done by general breast surgeons while in group B the oncoplastic procedures were done by well trained oncoplastic breast surgeons not assisted by plastic surgeons. The following data were reported in all cases including: age, family history, tumor size, volume and weight of the specimen, location of tumor, margin length, (primary tumor, regional nodes, metastasis) staging, molecular subtype and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadrantectomy group | Active comparator | Procedure: Standard quadrantectomy35 female patients with non metastatic breast cancer who had standard conservative breast surgery by general breast surgeons. |
| oncoplastic group | Active comparator | Procedure: oncoplastic breast surgery35 female patients with non metastatic breast cancer who had oncoplastic techniques for tumor resection by well trained oncoplastic breast surgeons. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Stage 1, 2 breast cancer
- Non metastatic breast caner
- Singing informed consent
Key exclusion criteria (9 listed)
- Metastatic breast cancer
- Stage 3, 4 breast cancer
- Inflammatory breast cancer
- Multicentric/multifocal disease
- Ductal carcinoma in situ
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 |
|---|---|---|
| Standard quadrantectomystandard conservative surgery with no use of any plastic techniques | Procedure or surgery | Quadrantectomy group |
| oncoplastic breast surgeryIntegration of plastic techniques with oncological procedures | Procedure or surgery | oncoplastic group |
Primary outcome
Margins in all specimens measured in millimeters.
Time frame: two years.
Patient satisfaction assessed using questionnaire.
Time frame: Two years.
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 15 Sep 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Non Metastatic Breast Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Recruiting
Nutrition Awareness Among Women With Non-Metastatic Breast Cancer
Breast Cancer, Breast Cancer Metastatic
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Locally Advanced Breast Cancer, Metastatic Breast Cancer
Enrolling by invitationObservational study
Harvesting Cells for Experimental Cancer Treatments
Melanoma, Gastrointestinal Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
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?
A study testing Standard quadrantectomy and oncoplastic breast surgery in people with Non Metastatic 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 3 inclusion and 9 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 15 Sep 2016. 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?
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?
Margins in all specimens measured in millimeters. (time frame: two years.). The study lists 2 primary outcomes in all. 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 15 Sep 2016.