Patient information combined for local therapy outcome assessment in bresast cancer.
- Conditions
- breast cancer10006232carcinoma of the breast
- Registration Number
- NL-OMON41193
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Women who have undergone breast conserving surgery for early breast cancer more than one year ago.
Written informed consent obtained.
Exclusion Criteria
Unable to provide written informed consent.
Younger than 18 years.
Benign breast disease.
Women who have had a mastectomy.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective will be to create a reliable demonstrator (software) by<br /><br>integrating models of surgical techniques and treatment schemes, clinical<br /><br>patient data, multimodal imaging and individualised models of patient anatomy. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective will be to assess the health related quality of life in<br /><br>the women who are participating in this study.<br /><br>The information obtained from this study will be used in the creation of a<br /><br>demonstrator (personalised digital representation of a patient) by integrating<br /><br>models of surgical techniques and treatment schemes, clinical patient data,<br /><br>multimodal imaging and individualised models of patient anatomy.<br /><br><br /><br>The aim is to create a demonstrator that will be used as an aid to objective<br /><br>surgical planning, via simulation of the cosmetic effects of breast conserving<br /><br>surgery, as a decision support tool to communicate the available options to the<br /><br>patient and to enable standardised evaluation of the procedure.</p><br>