Scar placement over the tumour versus hidden locations in breast-conserving surgery
Comparison of Patient Reported and Clinical Outcome Measures Based on Scar Placement in Patients Undergoing Breast Conserving Surgery (PROM-S Study)
This project will test whether placing the scar over the tumour versus in hidden locations changes patient satisfaction and clinical outcomes for women having standard breast-conserving surgery for breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Leeds Teaching Hospitals NHS Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Leeds, West Yorkshire) |
| Trial ID | NCT07116642 on ClinicalTrials.gov |
What this trial studies
This observational study will compare patient-reported outcomes and clinical results for women undergoing standard breast-conserving surgery with scars placed either directly over the lesion or in remote/hidden locations. Participants will complete the validated BREAST-Q questionnaire to measure satisfaction, appearance, and function after surgery, with comparisons made between the two scar-location groups. The study includes adult women with invasive cancer or DCIS eligible for breast-conserving surgery and collects short- and longer-term PROMs and clinical outcome data. Results aim to inform counselling about scar placement choices during surgical planning.
Who should consider this trial
Good fit: Women aged 18 and over with invasive breast cancer or DCIS who are suitable for standard breast-conserving surgery and can complete questionnaires are ideal candidates.
Not a fit: Male or transgender patients and those requiring oncoplastic volume-replacement procedures or mastectomy are excluded and unlikely to benefit directly from these findings.
Why it matters
Potential benefit: If successful, the results could help surgeons and patients choose scar placements that improve satisfaction and cosmetic outcomes after breast-conserving surgery.
How similar studies have performed: There is limited prior research directly comparing scar placement using BREAST-Q PROMs, so this approach is relatively novel for informing patient-reported outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients ≥18 years of age * Able to provide written informed consent * Invasive breast cancer or ductal carcinoma in situ (DCIS) suitable for sBCS (including multifocal cancers requiring x2 wires or magseeds) * Able to understand and complete the questionnaire Scar over the lesion defined as radial, transverse, vertical, oblique scar over the tumour lesion location in the breast Remote incisions defined as lateral perimeter/periareolar/infra-mammary fold/ benelli/hemi-batwing * No restrictions on tumour size (decision on suitability for sBCS will be based on clinical assessment) * Any axillary nodal staging status * Bilateral cancers allowed * Post neo-adjuvant chemotherapy (NACT) allowed Exclusion Criteria: * Male patients (BCS not proven as standard of care) or transgender * Patients undergoing oBCS (such as wise pattern, vertical scar mastopexy incision pattern or volume replacement chest wall perforator flap) * Patients undergoing mastectomy with or without immediate autologous or implant reconstruction * Patients requiring nipple excision (central wide local excision) * Patients undergoing wide local excision under local anaesthetic * Women not able or willing to give informed consent * Where close tumour proximity to skin or skin involvement necessitates skin excision over the tumour * Patients diagnosed with locoregional recurrence * Patients diagnosed with associated distant metastasis * Patients undergoing diagnostic excision surgery for atypical breast lesions or benign lesions * Patients diagnosed with phyllodes lesion * Patients who have had previous ipsilateral breast surgery (any type)
Where this trial is running
Leeds, West Yorkshire
- St James's University Hospital — Leeds, West Yorkshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sue Dr Hartup, PhD, RN — Leeds Teaching Hospitals NHS Trust
- Study coordinator: Sue M Dr Hartup, PhD, RGN
- Email: s.hartup@nhs.net
- Phone: +44 0113 2068628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.