Identifying factors that predict the need for increased tissue removal during breast-conserving surgery for breast cancer, in order to reduce the need for a second surgery

Pre-operative patient and tumor characteristics associated with increased risk of non-radical margins after breast-conserving surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN32164784

Enrollment

779

Registered

2019-11-21

Start date

2015-01-01

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer patients operated on using breast-conserving surgery Surgery

Interventions

All female patients operated with breast-conserving surgery for pre-stages of breast cancer or with breast cancer at Skåne University Hospital in Malmö, Sweden during the years 2015-2016 will be inclu

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Female patients operated with breast-conserving surgery with a final diagnosis of in situ or invasive cancer at Skåne University Hospital 2015-2016 for study cohort or 2017 for validation cohort or at Kristianstad hospital in 2017 for external validation

Exclusion criteria

Exclusion criteria: 1. Male gender 2. Primary operation not coded as breast-conserving surgery 3. Neoadjuvant treatment 4. Benign final pathology result

Design outcomes

Secondary

Measure	Time frame
All measured retrospectively and extracted from medical records: Post-operative tumor and patient characteristics such as method of operation, indication method, pathology results from tumor and axilla, weight of excised lump and operation time	—

Primary

Measure	Time frame
All measured retrospectively and extracted from medical records: 1. Number of patients with non-radical breast conserving surgery after first procedure 2. Preoperative tumor and patient characteristics such as age, BMI, breast side and size, screening detection, palpability of tumor, location in breast, distance from mamilla, lymph node palpability and status, previous breast operations, radiographic characteristics and size, biopsy results	—

Measure

Time frame

All measured retrospectively and extracted from medical records: 1. Number of patients with non-radical breast conserving surgery after first procedure 2. Preoperative tumor and patient characteristics such as age, BMI, breast side and size, screening detection, palpability of tumor, location in breast, distance from mamilla, lymph node palpability and status, previous breast operations, radiographic characteristics and size, biopsy results

—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026