Breast CancerNCT02923635
A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision
A study testing Standard wide local excision. and oncoplastic breast surgery. in people with Breast Cancer, run by Ain Shams University.
Trial summary
The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and its impact on patient satisfaction. Read more about this study
- Who is it for?
- Ages Up to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard wide local excision. 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
- No sites listed yet
- Study dates
- Sep 2012to Jun 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
- Patients with macromastia in oncoplastic group.
- Tumors >20% of breast volume in oncoplastic group.
- Young patients in oncoplastic group
- Tumors in medial or central quadrants in oncoplastic group
Who cannot join
- Patients >60 years.
- Patients with co-morbidities in oncoplastic group.
- Tumors >20% of breast volume in standard group.
- Tumors in medial or central quadrants in standard group
About this study
Official title: A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision:Margin Length and Patient Satisfaction
The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and its impact on patient satisfaction.
Read the detailed description
This non-randomized prospective trial was conducted on70 female patients presented to tertiary breast unit-Ain Shams University hospitals with breast cancer during the period from September 2012 to February 2013. All patients sharing in the study signed an informed consent that was approved in the ethical committee held on April 2012. Patients were classified in two groups each one 35 patients: group (A) standard wide local excision and group (B) oncoplastic group. Standard wide local excision done by general breast surgeons while oncoplastic surgeries done by breast surgeon assisted by plastic surgeon. The following data were recorded: Age, family history, margin length, weight and volume of the specimen, margin status and patient satisfaction.
- Conditions
- Breast Cancer
- Being tested
- Standard wide local excision., oncoplastic breast surgery.
- Keywords
- Oncoplastic breast surgery, Standard Wide Local Excision
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard wide local excision.Procedure or surgery
Excision of breast cancer without integration of plastic technique
oncoplastic breast surgery.Procedure or surgery
Integration of plastic techniques with oncological surgery for resection of breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Standard Wide Local Excision group | Active comparator | Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques . Receives: Procedure: Standard wide local excision. |
| Oncoplastic group | Active comparator | Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures 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
Secondary outcomes (1)
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 posted4 Oct 2016 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionJun 2016
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
- 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
- NCT02923635
- Sponsor's protocol ID
- 006379
- Status last verified
- Oct 2016
- First submitted
- 2 Oct 2016
- Last updated
- 4 Oct 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 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision:Margin Length and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT02923635
- Acronym / sponsor ID
- 006379
- Conditions
- Breast Cancer
- Keywords
- Oncoplastic breast surgery, Standard Wide Local Excision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Oct 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, and its impact on patient satisfaction.
Detailed description
This non-randomized prospective trial was conducted on70 female patients presented to tertiary breast unit-Ain Shams University hospitals with breast cancer during the period from September 2012 to February 2013. All patients sharing in the study signed an informed consent that was approved in the ethical committee held on April 2012. Patients were classified in two groups each one 35 patients: group (A) standard wide local excision and group (B) oncoplastic group. Standard wide local excision done by general breast surgeons while oncoplastic surgeries done by breast surgeon assisted by plastic surgeon. The following data were recorded: Age, family history, margin length, weight and volume of the specimen, margin status 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 |
|---|---|---|
| Standard Wide Local Excision group | Active comparator | Procedure: Standard wide local excision.Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques . |
| Oncoplastic group | Active comparator | Procedure: oncoplastic breast surgery.Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures |
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with macromastia in oncoplastic group.
- Tumors >20% of breast volume in oncoplastic group.
- Young patients in oncoplastic group
- Tumors in medial or central quadrants in oncoplastic group
Key exclusion criteria (4 listed)
- Patients >60 years.
- Patients with co-morbidities in oncoplastic group.
- Tumors >20% of breast volume in standard group.
- Tumors in medial or central quadrants in standard group
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 wide local excision.Excision of breast cancer without integration of plastic technique | Procedure or surgery | Standard Wide Local Excision group |
| oncoplastic breast surgery.Integration of plastic techniques with oncological surgery for resection of breast cancer. | Procedure or surgery | Oncoplastic group |
Primary outcome
Margins in all specimens measured in millimeters
Time frame: Two years
1 secondary outcome
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 4 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Questions about this trial
What is this clinical trial studying?
A study testing Standard wide local excision. and oncoplastic breast surgery. in people with Breast Cancer, run by Ain Shams University.
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: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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). 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 4 Oct 2016.