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TUmour-volume to breast-volume RAtio for Improving COSmetic Results in Breast Cancer Patients (TURACOS); a randomised controlled trial.

TUmour-volume to breast-volume RAtio for Improving COSmetic Results in Breast Cancer Patients (TURACOS); a randomised controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21871
Enrollment
240
Registered
2015-02-17
Start date
2015-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Breast conserving surgery, breast cancer, Quality of Life

Interventions

Performing a three-dimensional ultrasonography to measure tumour volume and breast volume. The volume ratio will be translated using a prediction model aiming for superior cosmetic results in breast c

Sponsors

C. Verhoef, Head of department & Surgeon Department of Oncological Surgery Erasmus MC-Daniel den Hoed 010-7041506
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Female Primary breast cancer Pathologically proven breast cancer stage I-III Aged > 18 years Eligible for breast conserving surgery (BCS)

Exclusion criteria

Exclusion criteria: Recurrent breast cancer ipsilateral Previous radiation therapy ipsilateral breast

Design outcomes

Primary

MeasureTime frame
Cosmetic outcome assessed through an independent panel.

Secondary

MeasureTime frame
1) Cosmetic result as assessed by the patient herself, Timepoint; prior to surgery, 2 weeks/3 months/1 year and 3 years after initial surgery. 2) cosmetic result as assessed by an objective asymmetry measurement, Timepoint; 2 weeks/3 months/1 year and 3 years after initial surgery. 3) surgical strategy/strategies performed 2 weeks/3 months/1 year and 3 years after initial surgery. 4) pathological result 2 weeks/3 months/1 year and 3 years after initial surgery. 5) patient satisfaction and 6) quality of life 7) radiation toxicity and 8) cost-effectiveness all will be conducted at Timepoint; 2 weeks/3 months/1 year and 3 years after initial surgery.

Contacts

Public ContactL.B. Koppert,

Department of Surgery, Erasmus MC Cancer Institute PO Box 5201

l.koppert@erasmusmc.nl(010-70)41161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)