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Factors Influencing Breast Cancer Resection Volumes And Their Impact on Treatment Outcome (FIBRATIO)

NCT05257577 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2024-04-24

No results posted yet for this study

Summary

The number of breast cancer survivors is constantly growing. Breast conserving surgery (BCS) is equal or superior to mastectomy both regarding survival and quality of life (QoL). Hence, as many patients as possible should be treated using BCS. The results indicate that the rate of mastectomies in Finland is higher than in Europe, while the rate of reoperations due to insufficient margins after BCS is lower in Finland than globally. With this study we aim to identify the optimal balance of radicality and tissue-conservation in BCS.

The aim of this study is to measure the volume of the resected breast tissue and the width of the healthy tissue margins and to compare these with the radiological and histological tumor size and with the size of the breast and their correlation with theoretically optimal and excised volumes.

This is a national prospective multicenter study conducted in five breast units. 250 women with primary, unilateral, cTis-T2 breast cancer eligible for BCS will be recruited. The diagnostics and treatment of the patients will be carried out following the Finnish national guideline. The size of the breast and the radiological size of the tumor will be measured preoperatively using mammograms and MRI. The histological tumor volume and the resection volume will be measured postoperatively. The optimal resection volume is calculated as the difference of the total resection volume and the volume of the tumor with an added 1 cm margin.

To map the impact of the treatment on QoL and body image, the patients are surveyed using EORTC-QLQ-C30 and BREAST-Q Breast Conserving Therapy Module QoL questionnaires preoperatively, 3-8 weeks postoperatively, and two years after the radiotherapy. Objective evaluation of the aesthetic outcome is assessed by the BCCT.core software that uses medical photographs taken at the same time points as the questionnaires are filled.

Conditions

  • Breast Cancer
  • Quality of Life
  • Patient Satisfaction
  • Resection Margin
  • Surgical Margin
  • Multidisciplinary Communication

Interventions

PROCEDURE

Breast conserving surgery

Patients receive standard of care breast surgery and subsequent whole breast irradiation

Sponsors & Collaborators

  • Jyväskylä Central Hospital

    collaborator OTHER

  • Turku University Hospital

    collaborator OTHER_GOV

  • Kuopio University Hospital

    collaborator OTHER

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Niku KJ Oksala, Professor · Tampere University Hospital, Tampere University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-28
Primary Completion
2027-03-30
Completion
2027-03-30

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257577 on ClinicalTrials.gov