Cosmetic and Functional Outcomes After Breast Conserving Surgery

This study is currently recruiting participants.

Verified December 2011 by National Institute of Oncology, Hungary

Sponsor:

Information provided by (Responsible Party):

Dr. Zoltan Matrai, National Institute of Oncology, Hungary

ClinicalTrials.gov Identifier:

NCT01496001

First received: December 12, 2011

Last updated: December 29, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 12, 2011
Last Updated Date	December 29, 2011
Start Date ^ICMJE	March 2011
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 20, 2011)	Primary outcome is the determination of the critical tumor / breast volume ratio in each quadrant, above of which number breast conserving surgery could not offer adequate cosmetic and functional results. [ Time Frame: 8 months ] [ Designated as safety issue: No ] Data of eligible patients are recorded by the study physicians on a locally developed questionnaire. Digital photos are taken of each patient producing a frontal and two side views. Images are processed by the BCCT.core software (Breast Cancer Conservation Treatment. cosmetic results). Magnetic resonance imaging is implemented and used to calculate breast volume with the help of Amira 5.1 software (Visage Imaging GmbH)trial version. Excised tumor is measured by a validated analytical scale.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01496001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 20, 2011)	Assessing the clinical applicability of the Breast Cancer Treatment Outcome Scale (BCTOS). [ Time Frame: 8 months for each patient ] [ Designated as safety issue: No ] Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken. Assessing the relationship between cosmetic+functional results and quality of life. [ Time Frame: 8 months for each patient ] [ Designated as safety issue: No ] Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software. Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken. Assessing the effect of surgical intervention on cosmetic+functional results and quality of life. [ Time Frame: During 8 postoperative months ] [ Designated as safety issue: Yes ] Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software. Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken. Assessing the effect of radiotherapeutical intervention on cosmetic+functional results and quality of life. [ Time Frame: During 8 postoperative months ] [ Designated as safety issue: Yes ] Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software. Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken. Assessing the clinical applicability of the European Organisation of Research and Treatment of Cancer, Quality of Life Questionnaire C30-BR23 (EORTC QoL C30-BR23) validated questionnaire. [ Time Frame: 8 months ] [ Designated as safety issue: No ] Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken. Assessing the clinical applicability of the BCCT.core software. [ Time Frame: 8 months ] [ Designated as safety issue: No ] Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cosmetic and Functional Outcomes After Breast Conserving Surgery
Official Title ^ICMJE	The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study
Brief Summary	The initial aesthetic and functional conditions are recorded with the help of the Breast Cancer Treatment Outcome Scale (BCTOS),an international validated questionnaire, and the Breast Cancer Conservative Treatment - cosmetic results (BCCT.core) validated computer software, allowing for comparison. Determination of the initial quality of life is measured with the European Organisation of Research and Treatment of Cancer - Quality of Life Questionnaire number C30-BR23 (EORTC QoL C30-BR23). Patients then undergo surgical treatment according to institutional protocols. Following conventional marking of the orientation of the specimen, it is measured by an analytical scale. Histological examination of the specimen will record the largest diameters, and parameters of the lymph nodes, according to the institutional protocol. On the 4th week following surgery, assuming that wound healing is completed, patients' data are again recorded in BCTOS, BCCT.core and EORTC QoL C30-BR23. A third set of data are gained after completion of adjuvant radiotherapy, on the 8th postoperative month. Magnetic resonance imaging is performed to assess the volume of the contralateral breast. Tumor - breast volume ratio is calculated, and matched up with cosmetic results in each quadrant, threshold value in the quadrants, above of which it is not advisable to perform conventional breast conserving surgery due to poor outcomes.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	Procedure: Lumpectomy, axillary block dissection, breast conserving surgery Wide excision of primary tumor (using 1 cm surgical margins). Minimally invasive biopsy of the sentinel lymph node. Other: Radiotherapy Adjuvant radiotherapy carried out by institutional protocols.
Study Arm (s)	Experimental: Cohort Interventions: Procedure: Lumpectomy, axillary block dissection, breast conserving surgery Other: Radiotherapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	300
Completion Date	Not Provided
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: early breast cancer unilateral tumor tumor size is less than 3 cm Exclusion Criteria: age over 70 malignant invasive tumor in the past pregnancy previous surgical treatment of the breast or axilla central breast tumor sizing <3 cm a need for mastectomy tumor size >3 cm measured by mammography or physical examination surgical excisions resulting in positive margins surgical or radiotherapeutic complication
Gender	Female
Ages	up to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Hungary

Administrative Information
NCT Number ^ICMJE	NCT01496001
Other Study ID Numbers ^ICMJE	NIO-BCS-QoL
Has Data Monitoring Committee	Yes
Responsible Party	Dr. Zoltan Matrai, National Institute of Oncology, Hungary
Study Sponsor ^ICMJE	National Institute of Oncology, Hungary
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute of Oncology, Hungary
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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