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Three-Dimensional Ultrasound Volume Ratio for Improving Cosmetic Results in Breast Cancer Patients; TURACOS trial

Three-Dimensional Ultrasound Volume Ratio for Improving Cosmetic Results in Breast Cancer Patients; TURACOS trial - TURACOS trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47039
Enrollment
300
Registered
2013-11-11
Start date
2015-10-05
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

breast cancer Breast carcinoma

Interventions

All patients will undergo the Automated Breast Volume Scanner (ABVS) at the department of radiology, Erasmus MC Cancer Institute. Tumor Volume and Breast Volume will be measured and a Volume Ratio w
1) EORTC/EQ-5D-5L quality of life questionnaires, and 2) about the expectations regarding cosmetic result (BREAST-Q). Pre- and postoperatively (1 and 3 year after initial operation) the professiona

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female breast cancer patients - Breast conserving surgery is optional and taken into consideration - Lesion visible at ultrasound

Exclusion criteria

Exclusion criteria: - Local recurrence of breast cancer - Contraindication for combined oncological and reconstructive surgery

Design outcomes

Primary

MeasureTime frame
Primary outcome is cosmetic result as assessed by an independent panel.

Secondary

MeasureTime frame
Second outcomes are: 1) cosmetic result as assessed by the patient herself, 2) cosmetic result as assessed by an objective asymmetry measurement, 3) surgical technique performed, 4) pathological result (radicality and quantitative specimen volume), 5) patient satisfaction and, 6) quality of life, and 7) cost efficacy regarding less irradicality.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)