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Search / Trial 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.

Launched by THE LEEDS TEACHING HOSPITALS NHS TRUST · Aug 6, 2025

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

Breast Cancer Surgery Patient Reported Outcomes

ClinConnect Summary

This study is looking at how the placement of surgical scars affects women’s satisfaction and quality of life after breast-conserving surgery for breast cancer. Breast-conserving surgery is a common treatment where only the cancerous part of the breast is removed, and this study compares scars made directly over the cancer with scars placed in other areas of the breast to see if one option leads to better patient experiences. Using a special questionnaire called BREAST-Q, researchers want to understand if scar location impacts how patients feel about their appearance and overall well-being after surgery.

Women aged 18 or older with breast cancer that can be treated with breast-conserving surgery may be eligible to join. Participation won’t change the type of surgery or scar placement recommended by the doctor. If you take part, you’ll be asked to complete the BREAST-Q questionnaire before surgery, then again at 2 weeks, 3 months, and 12 months after surgery. This will help the research team learn more about patient satisfaction over time and guide future care to improve outcomes for women undergoing this surgery.

Gender

FEMALE

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)

About The Leeds Teaching Hospitals Nhs Trust

The Leeds Teaching Hospitals NHS Trust is a prominent healthcare organization in the United Kingdom, renowned for its commitment to delivering high-quality patient care, innovative research, and advanced medical education. As a leading clinical trial sponsor, the Trust plays a pivotal role in facilitating cutting-edge research initiatives that aim to improve health outcomes and advance medical knowledge. With a multidisciplinary team of experts and access to state-of-the-art facilities, the Trust is dedicated to fostering collaboration and ensuring the highest ethical standards in clinical research, ultimately contributing to the development of new treatments and therapies for diverse patient populations.

Locations

Leeds, West Yorkshire, United Kingdom

Patients applied

0 patients applied

Trial Officials

Sue Dr Hartup, PhD, RN

Principal Investigator

Leeds Teaching Hospitals NHS Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported