NCT07116642 Comparing Patient Reported Outcomes and Clinical Outcomes Based on Different Scar Placement in Patients Undergoing Standard Breast Conserving Surgery for Breast Cancer: The PROM-S Study.
| NCT ID | NCT07116642 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Leeds Teaching Hospitals NHS Trust |
| Condition | Breast Cancer - Female |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2026-12 |
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 100 participants in total. It began in 2025-02-20 with a primary completion date of 2026-12.
⚠ 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
This study is for patients with breast cancer and the objective is to compare patient reported outcome measures (PROMs) based on scar placement in patients undergoing standard breast-conserving surgery (sBCS). BCS has become the standard of care for eligible patients with breast cancer (current UK national BCS rate is 60%). Scar placement for sBCS can be divided into two groups: those directly over the cancer, or those in remote locations (e.g. around the nipple, near the armpit, the lower part of the breast, where the breast and the chest meet etc.) with the aim of hiding the scar in more visually acceptable locations on the breast. Multiple factors determine where the scar is placed such as aesthetics, other health conditions, location of the cancer, etc. However, it is currently unclear whether the location of scar placement for sBCS affects patient reported outcomes. The growing importance on breast cosmesis has led to more attention from clinicians and patients with regards to the selection of surgical incision placement for sBCS. By using a validated questionnaire (BREAST-Q), we wish to assess if there is any difference in PROMs based on scar placement (over the lesion vs. remote) in patients undergoing sBCS. It is anticipated that the study results will help champion and guide care for future breast cancer patients, as well as providing an insight into how patient satisfaction may vary between different sBCS approaches. This questionnaire study will include consecutive patients undergoing sBCS at Leeds Teaching Hospitals NHS Trust. Participation in this non-randomised study will not impact on routine clinical care or decision making for the type of surgery planned or scar placement choice. Patients will be asked to complete the BREAST-Q questionnaire prior to surgery, after 2 weeks, as well as 3 and 12 months after surgery.
Eligibility 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)
Contact & Investigator
Sue Dr Hartup, PhD, RN
PRINCIPAL INVESTIGATOR
Leeds Teaching Hospitals NHS Trust
Frequently Asked Questions
Who can join the NCT07116642 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer - Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07116642 currently recruiting?
Yes, NCT07116642 is actively recruiting participants. Contact the research team at s.hartup@nhs.net for enrollment information.
Where is the NCT07116642 trial being conducted?
This trial is being conducted at Leeds, United Kingdom.
Who is sponsoring the NCT07116642 clinical trial?
NCT07116642 is sponsored by The Leeds Teaching Hospitals NHS Trust. The principal investigator is Sue Dr Hartup, PhD, RN at Leeds Teaching Hospitals NHS Trust. The trial plans to enroll 100 participants.
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