Breast Image Scale Index for Self Esteem EvaluationiTOPNCT01396993
Prospective Non-randomized Evaluation of Oncoplastic Surgery
An observational study of Breast Image Scale Index for Self Esteem Evaluation and Breast Symmetry Index, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are sometimes poor reducing the quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Image Scale Index for Self Esteem Evaluation, Breast Symmetry Index, Quality of Life
- What is being tested?
- Breast Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2011to Aug 2016
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a BIRADS IV, V or VI breast lesion are preoperatively asked to take part in this study if more than 10% of breast tissue will be excised or mastectomy and immediate reconstruction is planned. Patients with planned mastectomy without immediate reconstruction are not included. Patients scheduled for breast conservation can decide whether they undergo regular breast conservation (BCT) or BCT using immediate techniques of oncoplastic surgery (iTOP). A contralateral correction may be performed in both groups at any time of the trial. The use of a contralateral correction of patients without an immediate oncoplastic procedure does not initiate a change into the other group (intention to treat analyses).
Who may be able to join
- Patients scheduled for unilateral breast conserving surgery due to cancer or a suspicious lesion, in whom >10%* of breast volume (measured by mammograms using a defined formular 37) has to be removed or breast cancer patients scheduled for mastectomy and immediate reconstruction (immediate or delayed contralateral correction is allowed)
- BIRADS IV, V or VI are eligible
- > 18 years of age
- Psychological and physical capable of understanding and performing the trial
- Signed written informed consent * If oncologic safety necessitates to resect more than half of one breast quadrant
Who cannot join
- Inflammatory breast cancer
- Progression after neoadjuvant therapy
- Pregnant women
- Patients unable to perform surgery under general anaesthesia
- Bilateral breast lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer
Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has been demonstrated by several authors using restrospective analyses. However, no prospective observational trial has been done to objectively evaluate cosmetic and oncologic outcome comparing BCT with iTOP. The aim of this study is to investigate this issue within a prospective non randomized observational trial at the Medical University Vienna.
- Conditions
- Breast Image Scale Index for Self Esteem Evaluation, Breast Symmetry Index, Quality of Life, Morbidity, Oncological Outcome
- Being tested
- Breast Surgery
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 AND immediate defect filling using local flaps (level I) or reduction plastics (level II) as well as mastectomy and immediate reconstruction using free flaps
Breast SurgeryProcedure or surgery
Breast conserving therapy without defect correction
| Study group | Role | What they receive |
|---|---|---|
| iTOP | Patients undergoing immediate techniques for oncoplastic surgery (level I only parenchmyl rotation and breast undermining as well as level II using complex reduction plastics for nipple-areola-complex movings) and patients with mastectomy and immediate reconstruction Receives: Procedure: Breast Surgery | |
| BCT | patients undergoing conservative breast surgery Receives: Procedure: Breast Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast image scale
self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.
Measured: 2 years
Secondary outcomes (4)
quality of life
BREAST Q, non-validated questionnaires
Measured: 2 years
Morbidity
Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery
Measured: 6 months
breast symmetry index
Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery
Measured: 2 years
oncologic parameters
local, distent and overal survival 2 as well as 5 years after surgery will be assessed
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2015
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Image Scale Index for Self Esteem EvaluationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Fitzal, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396993
- Sponsor's protocol ID
- iTOP
- Acronym
- iTOP
- Status last verified
- Sep 2015
- First submitted
- 18 Jul 2011
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer
- ClinicalTrials.gov ID
- NCT01396993
- Acronym / sponsor ID
- iTOP / iTOP
- Conditions
- Breast Image Scale Index for Self Esteem Evaluation, Breast Symmetry Index, Quality of Life, Morbidity, Oncological Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 19 Jul 2011 (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.
Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has been demonstrated by several authors using restrospective analyses. However, no prospective observational trial has been done to objectively evaluate cosmetic and oncologic outcome comparing BCT with iTOP. The aim of this study is to investigate this issue within a prospective non randomized observational trial at the Medical University Vienna.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTOP | – | Procedure: Breast SurgeryPatients undergoing immediate techniques for oncoplastic surgery (level I only parenchmyl rotation and breast undermining as well as level II using complex reduction plastics for nipple-areola-complex movings) and patients with mastectomy and immediate reconstruction |
| BCT | – | Procedure: Breast Surgerypatients undergoing conservative breast surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a BIRADS IV, V or VI breast lesion are preoperatively asked to take part in this study if more than 10% of breast tissue will be excised or mastectomy and immediate reconstruction is planned. Patients with planned mastectomy without immediate reconstruction are not included. Patients scheduled for breast conservation can decide whether they undergo regular breast conservation (BCT) or BCT using immediate techniques of oncoplastic surgery (iTOP). A contralateral correction may be performed in both groups at any time of the trial. The use of a contralateral correction of patients without an immediate oncoplastic procedure does not initiate a change into the other group (intention to treat analyses).
Key inclusion criteria (5 listed)
- Patients scheduled for unilateral breast conserving surgery due to cancer or a suspicious lesion, in whom >10%* of breast volume (measured by mammograms using a defined formular 37) has to be removed or breast cancer patients scheduled for mastectomy and immediate reconstruction (immediate or delayed contralateral correction is allowed)
- BIRADS IV, V or VI are eligible
- > 18 years of age
- Psychological and physical capable of understanding and performing the trial
- Signed written informed consent * If oncologic safety necessitates to resect more than half of one breast quadrant
Key exclusion criteria (5 listed)
- Inflammatory breast cancer
- Progression after neoadjuvant therapy
- Pregnant women
- Patients unable to perform surgery under general anaesthesia
- Bilateral breast lesions
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 AND immediate defect filling using local flaps (level I) or reduction plastics (level II) as well as mastectomy and immediate reconstruction using free flaps | Procedure or surgery | iTOP |
| Breast SurgeryBreast conserving therapy without defect correction | Procedure or surgery | BCT |
Primary outcome
breast image scale
Time frame: 2 years
self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.
4 secondary outcomes
quality of life
Time frame: 2 years
Morbidity
Time frame: 6 months
breast symmetry index
Time frame: 2 years
oncologic parameters
Time frame: 2-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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 Image Scale Index for Self Esteem Evaluation and Breast Symmetry Index, run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 5 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 23 Sep 2015. 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 Austria. 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?
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?
breast image scale (time frame: 2 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 23 Sep 2015.