Breast CancerNCT01496001
Cosmetic and Functional Outcomes After Breast Conserving Surgery
A study testing Lumpectomy, axillary block dissection, breast conserving surgery and Radiotherapy in people with Breast Cancer, run by National Institute of Oncology, Hungary at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Lumpectomy, axillary block dissection, breast conserving surgery and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteHungary
- Study dates
- Mar 2011to Jan 2015
- 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 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- early breast cancer
- unilateral tumor
- tumor size is less than 3 cm
Who cannot join
- 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
Show all 9Show fewer
- tumor size >3 cm measured by mammography or physical examination
- surgical excisions resulting in positive margins
- surgical or radiotherapeutic complication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study
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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Lumpectomy, axillary block dissection, breast conserving surgery, Radiotherapy
- Keywords
- Early unilateral breast cancer
- Medical subject headings
- Breast Neoplasms, Unilateral Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumpectomy, axillary block dissection, breast conserving surgeryProcedure or surgery
Wide excision of primary tumor (using 1 cm surgical margins). Minimally invasive biopsy of the sentinel lymph node.
RadiotherapyOther
Adjuvant radiotherapy carried out by institutional protocols.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Not described Receives: Procedure: Lumpectomy, axillary block dissection, breast conserving surgery; Other: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 8 months
Secondary outcomes (6)
Assessing the clinical applicability of the Breast Cancer Treatment Outcome Scale (BCTOS).
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.
Measured: 8 months for each patient
Assessing the relationship between cosmetic+functional results and quality of life.
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.
Measured: 8 months for each patient
Assessing the effect of surgical intervention on cosmetic+functional results and quality of life.
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.
Measured: During 8 postoperative months
Assessing the effect of radiotherapeutical intervention on cosmetic+functional results and quality of life.
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.
Measured: During 8 postoperative months
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.
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.
Measured: 8 months
Assessing the clinical applicability of the BCCT.core software.
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2015
- Study completionJan 2015
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Oncology, Hungary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Zoltan Matrai, National Institute of Oncology, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496001
- Sponsor's protocol ID
- NIO-BCS-QoL
- Status last verified
- Oct 2015
- First submitted
- 12 Dec 2011
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01496001
- Acronym / sponsor ID
- NIO-BCS-QoL
- Conditions
- Breast Cancer
- Keywords
- Early unilateral breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- National Institute of Oncology, HungaryUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 21 Dec 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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Procedure: Lumpectomy, axillary block dissection, breast conserving surgery, Other: Radiotherapy |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- early breast cancer
- unilateral tumor
- tumor size is less than 3 cm
Key exclusion criteria (9 listed)
- age over 70
- malignant invasive tumor in the past
- pregnancy
- previous surgical treatment of the breast or axilla
- central breast tumor sizing <3 cm
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 |
|---|---|---|
| Lumpectomy, axillary block dissection, breast conserving surgeryWide excision of primary tumor (using 1 cm surgical margins). Minimally invasive biopsy of the sentinel lymph node. | Procedure or surgery | Cohort |
| RadiotherapyAdjuvant radiotherapy carried out by institutional protocols. | Other | Cohort |
Primary outcome
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
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.
6 secondary outcomes
Assessing the clinical applicability of the Breast Cancer Treatment Outcome Scale (BCTOS).
Time frame: 8 months for each patient
Assessing the relationship between cosmetic+functional results and quality of life.
Time frame: 8 months for each patient
Assessing the effect of surgical intervention on cosmetic+functional results and quality of life.
Time frame: During 8 postoperative months
Assessing the effect of radiotherapeutical intervention on cosmetic+functional results and quality of life.
Time frame: During 8 postoperative months
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
Assessing the clinical applicability of the BCCT.core software.
Time frame: 8 months
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 6 Oct 2015.
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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 Lumpectomy, axillary block dissection, breast conserving surgery and Radiotherapy in people with Breast Cancer, run by National Institute of Oncology, Hungary at 1 site in Hungary.
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 6 Oct 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 Hungary. 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?
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). 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 6 Oct 2015.