NCT04349527 Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries
| NCT ID | NCT04349527 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Oncology, Hungary |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 242 participants |
| Start Date | 2020-04-18 |
| Primary Completion | 2022-04-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 242 participants in total. It began in 2020-04-18 with a primary completion date of 2022-04-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this clinical study is to analyze due long term follow-up, the clinical, oncological, aesthetic results and patients' reported quality of life and satisfaction in a responsive-adaptive (RAR) prospective, randomized study at a large number of patients whom receive round-block and retroglandular oncoplastic breast conserving surgeries. According to the study's hypothesis, breast conserving surgery can be oncologically successful and safe with low complication rates resulting in high rate of patient satisfaction and good quality of life, which can be maintained for a long time after WBI with the application of modern oncoplastic breast conserving surgeries. We assume in this study that against of the earliest and mostly studied round-block oncoplastic surgery, the retroglandular technique, firstly reported in the literature by the current authors, is also adequate for oncologically safe, radical tumor removal that comes with low complication rates, suited for adjuvant treatments and able to offer better cosmetic results (NAC does not distorted, and pathological scar will not develop) than round-block OPS and high rate of patient's satisfaction that can be maintained for long-term.
Eligibility Criteria
Inclusion Criteria: * \- Under the age of 65, suffering from unilateral (cT\< 3cm) in situ or invasive breast cancer, who are fit for breast conserving surgeries, who had no previous breast surgery, independent from axillary surgery (sentinel lymph node biopsy or axillary block dissection) Exclusion Criteria: * In case the patient does not volunteer for the examination or the follow-ups * Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without a tumor * Malignant invasive tumor in the past history (except for non-melanoma skin tumors) * Mastectomy performed due to positive resection margin * Prior breast surgery (e.g. aesthetic surgery, breast lift) and/or radiotherapy on the breast or in the axilla * Malignant tumor is not removed completely with pathological examination * Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results * Autoimmune diseases * Tumor requiring mastectomy, or clinically larger than 3 cm tumor primary, or mastitis carcinomatosa, lymphangitis carcinomatosa * Long-term steroid usage, which changed the skin's quality and structure * Patient under foster care, or psychically non-cooperative patient
Frequently Asked Questions
Who can join the NCT04349527 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04349527 currently recruiting?
Yes, NCT04349527 is actively recruiting participants. Visit ClinicalTrials.gov or contact National Institute of Oncology, Hungary to inquire about joining.
Where is the NCT04349527 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT04349527 clinical trial?
NCT04349527 is sponsored by National Institute of Oncology, Hungary. The trial plans to enroll 242 participants.
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